Non-small Cell Lung CarcinomaPhase 1/2NCT02039674

A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)

A Phase 1/2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with Non-small Cell Lung Carcinoma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Carcinoma
What is being tested?: Pembrolizumab, Paclitaxel and Carboplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 267 participants
Where: No sites listed yet
Study dates: 21 Feb 2014to 18 Oct 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage IIIb/IV NSCLC
Disease progression >1 year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease
Resolution of any toxic effects (excepting alopecia) of the most recent therapy
At least one radiographically measurable lesion
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale
Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents or tyrosine kinase inhibitors

Who cannot join

Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of pembrolizumab
Expected to require any other form of antineoplastic therapy while on study
Is on chronic systemic steroid therapy or on any other form of immunosuppressive medication
Has received a live-virus vaccination within 30 days of planned treatment start
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
History of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years

Show all 20Show fewer

Active central nervous system (CNS) metastases and/or carcinomatous meningitis
Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication
Radiation therapy to lung >30 Gy within 6 months of first dose of study medication
Prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study medication
Active infection requiring therapy
History of Human Immunodeficiency Virus (HIV)
Active Hepatitis B or C
Symptomatic ascites or pleural effusion
Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
Psychiatric disorders and substance (drug/alcohol) abuse

About this study

Official title: A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

Conditions: Non-small Cell Lung Carcinoma
Being tested: Pembrolizumab, Paclitaxel, Carboplatin, Bevacizumab, Pemetrexed
Keywords: PD-1, PD1, Programmed Cell Death-1, Programmed Cell Death 1, Chemotherapy, Pemetrexed, Paclitaxel, Bevacizumab, Erlotinib, Gefitinib, Ipilimumab, Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PembrolizumabBiological
Also called MK-3475, KEYTRUDA®, SCH 900475
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
PaclitaxelDrug
Also called ABRAXANE®
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
CarboplatinDrug
Also called PARAPLATIN®
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
BevacizumabBiological
Also called AVASTIN®
IV on Day 1 of each 3-week cycle
PemetrexedDrug
Also called ALIMTA®
IV on Day 1 of each 3-week cycle
IpilimumabBiological
Also called YERVOY®
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
ErlotinibDrug
Also called TARCEVA®
Orally tablet once daily
GefitinibDrug
Also called IRESSA®
Oral tablet once daily

Study groups in NCT02039674
Study group	Role	What they receive
Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])	Experimental	Cohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	Experimental	Cohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Biological: Bevacizumab
Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)	Experimental	Cohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])	Experimental	Cohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Biological: Ipilimumab
Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)	Experimental	Cohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet once a day on every day of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Erlotinib
Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)	Experimental	Cohort F participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via oral tablet once a day on every day of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Gefitinib
Part 2 Cohort G+ (Pembro 200mg+C+Pe)	Experimental	Cohort G+ participants receive pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed
Part 2 Cohort H (Pembro+I)	Experimental	Cohort H participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase II dose determined in Cohort D). Receives: Biological: Pembrolizumab; Biological: Ipilimumab
Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])	Experimental	Cohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])	Experimental	Cohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Biological: Bevacizumab
Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)	Experimental	Cohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed
Part 2 Cohort G- (Placebo+C+Pe)	Experimental	Cohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS. Receives: Drug: Carboplatin; Drug: Pemetrexed
Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])	Experimental	Cohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Biological: Ipilimumab
Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])	Experimental	Cohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle. Receives: Biological: Pembrolizumab; Biological: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Measured: Up to approximately 2 years
Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Measured: Up to approximately 2 years
All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
Measured: Cycle 1 (Up to 21 days)

Secondary outcomes (3)

Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.
Measured: Up to approximately 2 years
Part 2 Cohorts G+ and G-: Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Measured: Up to approximately 2 years
Part 2 Cohorts G+ and G-: Duration of Response (DOR)
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 201418 Oct 2021

First posted17 Jan 2014 (estimated)
Study start21 Feb 2014
Primary completion7 Nov 2016
Study completion18 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Non-small Cell Lung CarcinomaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02039674
Sponsor's protocol ID: 3475-021
Other IDs: MK-3475-021, KEYNOTE-021
Status last verified: Oct 2022
First submitted: 16 Jan 2014
Last updated: 8 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd

Publications

Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.
PubMed 27745820
Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.
PubMed 30138764
Cheng Y, Yang JC, Okamoto I, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Yan Y, Xiao S, Lin J, Pietanza MC, Kurata T. Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia. Immunotherapy. 2023 Sep;15(13):1029-1044. doi: 10.2217/imt-2023-0043. Epub 2023 Jul 19.
PubMed 37465924
Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.
PubMed 30529597
Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.
PubMed 30429032

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-small Cell Lung Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
ClinicalTrials.gov ID: NCT02039674
Acronym / sponsor ID: 3475-021
Conditions: Non-small Cell Lung Carcinoma
Keywords: PD-1, PD1, Programmed Cell Death-1, Programmed Cell Death 1, Chemotherapy, Pemetrexed, Paclitaxel, Bevacizumab
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 267 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Feb 2014
Primary completion: 7 Nov 2016 (actual)
Study completion: 18 Oct 2021 (actual)
First posted: 17 Jan 2014 (estimated)
Results: Posted 2 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 14

Arm	Type	Receives
Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])	Experimental	Biological: Pembrolizumab, Drug: Paclitaxel, Drug: CarboplatinCohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	Experimental	Biological: Pembrolizumab, Drug: Paclitaxel, Drug: Carboplatin, Biological: BevacizumabCohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)	Experimental	Biological: Pembrolizumab, Drug: Carboplatin, Drug: PemetrexedCohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])	Experimental	Biological: Pembrolizumab, Biological: IpilimumabCohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)	Experimental	Biological: Pembrolizumab, Drug: ErlotinibCohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet once a day on every day of each 3-week cycle.
Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)	Experimental	Biological: Pembrolizumab, Drug: GefitinibCohort F participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via oral tablet once a day on every day of each 3-week cycle.
Part 2 Cohort G+ (Pembro 200mg+C+Pe)	Experimental	Biological: Pembrolizumab, Drug: Carboplatin, Drug: PemetrexedCohort G+ participants receive pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
Part 2 Cohort H (Pembro+I)	Experimental	Biological: Pembrolizumab, Biological: IpilimumabCohort H participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase II dose determined in Cohort D).
Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])	Experimental	Biological: Pembrolizumab, Drug: Paclitaxel, Drug: CarboplatinCohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])	Experimental	Biological: Pembrolizumab, Drug: Paclitaxel, Drug: Carboplatin, Biological: BevacizumabCohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)	Experimental	Biological: Pembrolizumab, Drug: Carboplatin, Drug: PemetrexedCohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Part 2 Cohort G- (Placebo+C+Pe)	Experimental	Drug: Carboplatin, Drug: PemetrexedCohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS.
Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])	Experimental	Biological: Pembrolizumab, Biological: IpilimumabCohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])	Experimental	Biological: Pembrolizumab, Biological: IpilimumabCohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Stage IIIb/IV NSCLC
Disease progression >1 year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease
Resolution of any toxic effects (excepting alopecia) of the most recent therapy
At least one radiographically measurable lesion
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale

Key exclusion criteria (20 listed)

Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of pembrolizumab
Expected to require any other form of antineoplastic therapy while on study
Is on chronic systemic steroid therapy or on any other form of immunosuppressive medication
Has received a live-virus vaccination within 30 days of planned treatment start
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PembrolizumabAlso: MK-3475, KEYTRUDA®, SCH 900475IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy	Biological	Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C]), Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C]), Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B]), Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B]), Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C), Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C), Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I]), Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I]), Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I]), Part 1 Cohort E (Pembro 2mg/kg+Erlotinib), Part 1 Cohort F (Pembro 2mg/kg+Gefitinib), Part 2 Cohort G+ (Pembro 200mg+C+Pe), Part 2 Cohort H (Pembro+I)
PaclitaxelAlso: ABRAXANE®IV on Day 1 of each 3-week cycle for a maximum of 4 administrations	Drug	Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C]), Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C]), Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B]), Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
CarboplatinAlso: PARAPLATIN®IV on Day 1 of each 3-week cycle for a maximum of 4 administrations	Drug	Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C]), Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C]), Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B]), Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B]), Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C), Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C), Part 2 Cohort G+ (Pembro 200mg+C+Pe), Part 2 Cohort G- (Placebo+C+Pe)
BevacizumabAlso: AVASTIN®IV on Day 1 of each 3-week cycle	Biological	Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B]), Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
PemetrexedAlso: ALIMTA®IV on Day 1 of each 3-week cycle	Drug	Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C), Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C), Part 2 Cohort G+ (Pembro 200mg+C+Pe), Part 2 Cohort G- (Placebo+C+Pe)
IpilimumabAlso: YERVOY®IV on Day 1 of each 3-week cycle for a maximum of 4 administrations	Biological	Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I]), Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I]), Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I]), Part 2 Cohort H (Pembro+I)
ErlotinibAlso: TARCEVA®Orally tablet once daily	Drug	Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)
GefitinibAlso: IRESSA®Oral tablet once daily	Drug	Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)

Primary outcome

Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Time frame: Cycle 1 (Up to 21 days)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.

3 secondary outcomes

Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Part 2 Cohorts G+ and G-: Overall Survival (OS)
Time frame: Up to approximately 2 years
Part 2 Cohorts G+ and G-: Duration of Response (DOR)
Time frame: Up to approximately 2 years

Results and safety

Results posted to the registry on 2 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])	13	0
Part1 Cohort A10 (Pembro10mg/kg+Pa+C)	12	0
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	12	0
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)	13	0
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)	12	0
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)	12	0
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])	3	0
Part 1 Cohort D2 (Pembro 10 mg/kg+I)	3	0
Part 1 Cohort D4 (Pembro 2 mg/kg+I)	12	0
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)	12	0
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)	7	0
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	60	0
Part 2 Cohort G- (Placebo+Pe+C)	63	0
Part 2 Cohort H (Pembro 2mg/kg+I)	33	0

Primary outcome: Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)

Time frame: Up to approximately 2 years. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Part 2 Cohort G+ (Pembro 200 mg+Pe+C) n = 60	Part 2 Cohort G- (Placebo+Pe+C) n = 63
Value	55.0 (41.6 to 67.9)	28.6 (17.9 to 41.3)

Part 2 Cohort G+ (Pembro 200 mg+Pe+C) vs Part 2 Cohort G- (Placebo+Pe+C): Difference in Percentages: 26.3 (95% CI 8.9 to 42.1), p = 0.0016, Miettinen & Nurminen Method

Population analysed: The analysis population consisted of all randomized Cohort G participants (database cutoff date: 08 August 2016).

Primary outcome: Part 2 Cohorts D4 and H: Objective Response Rate (ORR)

Time frame: Up to approximately 2 years. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Part 2 Cohorts D4 & H (Pembro 2mg/kg+I) n = 44
Value	29.5 (16.8 to 45.2)

Part 2 Cohorts D4 & H (Pembro 2mg/kg+I): p = 0.0858, Exact binomial distribution for testing

Population analysed: The analysis population consisted of all treated Cohort D4 and Cohort H participants (database cutoff date: 07 November 2016). One Cohort H participant was excluded from the efficacy analysis population due to a protocol violation. This participant did not have non-small cell lung cancer.

Primary outcome: All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)

Time frame: Cycle 1 (Up to 21 days). Count of participants. Unit: Participants

Measure	Part1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C]) n = 13	Part1 Cohort A10 (Pembro10mg/kg+Pa+C) n = 12	Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B]) n = 11	Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B) n = 13	Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C) n = 12	Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C) n = 12	Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I]) n = 3	Part 1 Cohort D2 (Pembro 10 mg/kg+I) n = 3	Part 1 Cohort D4 (Pembro 2 mg/kg+I) n = 12	Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib) n = 12	Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib) n = 7	Part 2 Cohort G+ (Pembro 200 mg+Pe+C) n = 59	Part 2 Cohort G- (Placebo+Pe+C) n = 62	Part 2 Cohort H (Pembro 2 mg/kg+I) n = 33
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 92 months (Up to 90 days after last dose of study treatment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)	5 of 12 (41.7%)	12 of 12 (100%)	10 of 12
Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])	7 of 13 (53.8%)	13 of 13 (100%)	10 of 13
Cohort A Second Course (Pembro 2 mg/kg Monotherapy)	0 of 2 (0%)	0 of 2 (0%)	2 of 2
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)	8 of 13 (61.5%)	12 of 13 (92.3%)	11 of 13
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	8 of 11 (72.7%)	11 of 11 (100%)	9 of 12
Cohort B Second Course (Pembro 2 mg/kg Monotherapy)	0 of 1 (0%)	0 of 1 (0%)	1 of 1
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)	7 of 12 (58.3%)	12 of 12 (100%)	11 of 12
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)	6 of 12 (50%)	12 of 12 (100%)	8 of 12
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Part 1 Cohort D2 (Pembro 10 mg/kg+I)	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Part 1 Cohort D4 (Pembro 2 mg/kg+I)	5 of 12 (41.7%)	12 of 12 (100%)	11 of 12
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)	8 of 12 (66.7%)	12 of 12 (100%)	5 of 12
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)	5 of 7 (71.4%)	7 of 7 (100%)	7 of 7
Cohort E Second Course (Pembro 2 mg/kg Monotherapy)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	30 of 59 (50.8%)	58 of 59 (98.3%)	42 of 60
Part 2 Cohort G- (Placebo+Pe+C)	21 of 62 (33.9%)	60 of 62 (96.8%)	47 of 63
Cohort G+ Second Course (Pembro 200 mg Monotherapy)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27745820Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.
Results publication: PubMed 30138764Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.
Derived from this study: PubMed 37465924Cheng Y, Yang JC, Okamoto I, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Yan Y, Xiao S, Lin J, Pietanza MC, Kurata T. Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia. Immunotherapy. 2023 Sep;15(13):1029-1044. doi: 10.2217/imt-2023-0043. Epub 2023 Jul 19.
Derived from this study: PubMed 30529597Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.
Derived from this study: PubMed 30429032Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.
Merck Oncology Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with Non-small Cell Lung Carcinoma, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 2 Cohorts G+ and G-: Objective Response Rate (ORR) (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02039674, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.