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MSSPhase 2NCT03271047

Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation

A Phase 2 study testing binimetinib, nivolumab and ipilimumab in people with MSS and RAS-mutant Colorectal Cancer, run by Pfizer at 50 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MSS, RAS-mutant Colorectal Cancer
What is being tested?
binimetinib, nivolumab and ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
50 sitesin 5 countries
Study dates
18 Oct 2017to 25 Feb 2021
Phase
Phase 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

  • Measurable, histologically/cytologically confirmed metastatic colorectal cancer (mCRC).
  • Able to provide a sufficient amount of representative tumor specimen for central laboratory testing of RAS mutation status and microsatellite stable (MSS).
  • If a fresh tissue sample is provided, a blood sample is required.
  • Metastatic colorectal cancer (mCRC) categorized as microsatellite stable (MSS) by polymerase chain reaction (PCR) per local assay at any time prior to Screening or by the central laboratory.
  • RAS mutation per local assay at any time prior to Screening or by the central laboratory.
  • Have received at least 1 prior line of therapy and meets at least one of the following criteria:
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  • were unable to tolerate the prior first-line regimen
  • experienced disease progression during or after prior first-line regimen for metastatic disease
  • progressed during or within 3 months of completing adjuvant chemotherapy. Note: Generally, treatments that are separated by an event of progression are considered different regimens.
  • Have received no more than 2 prior lines of therapy (maintenance therapy given in the metastatic setting will not be considered a separate regimen). Generally, treatments that are separated by an event of progression are considered different regimens.
  • Adequate bone marrow, cardiac, kidney and liver function
  • Able to take oral medications
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of child-bearing potential
  • Non-sterile male patients who are sexually active with female partners of childbearing potential must agree to follow instructions for acceptable or highly effective method(s) of contraception for the duration of study treatment and for 7 months after the last dose of study treatment with nivolumab

Who cannot join

  • Prior treatment with any MEK inhibitor, an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Any untreated central nervous system (CNS) lesion.
  • Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Known history of retinal vein occlusion (RVO).
  • Known history of Gilbert's syndrome.
  • Pregnant or breastfeeding females.
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  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to first day of study treatment:
  • History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli.
  • Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.
  • Concurrent neuromuscular disorder that is associated with the potential of elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus.

Trial locations and contacts

50 sites in 5 countries.

50 sites in 5 countries

United States33 sites

  • Sarah Cannon Research Institute

    Chattanooga, Tennessee, 37404

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Siteman Cancer Center - Barnes St. Peters

    City of Saint Peters, Missouri, 63376

  • Tennessee Oncology, PLLC

    Cleveland, Tennessee, 37311

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana CTSI Clinical Research Center (ICRC)

    Indianapolis, Indiana, 46202

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Investigational Drug Services IUHSCC

    Indianapolis, Indiana, 46202

  • Sidney &Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • Spring Mill Medical Center

    Indianapolis, Indiana, 46290

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Tennessee Oncology NASH - SCRI - PPDS

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute.

    Nashville, Tennessee, 37203

  • Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy, Suite 3200

    Newark, Delaware, 19713

  • Christiana Care Health Services, Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Oncology Hematology, Helen F Graham Cancer Center, Suite 2400

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health Services, Christiana Hospital

    Newark, Delaware, 19718

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Investigational Drug Service of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

  • Center for Outpatient Health (Dermatology Clinic)

    St Louis, Missouri, 63108

  • Center for Outpatient Health (Ophthalmology Clinic)

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Georgetown University Medical Center Department of Pharmacy, Research

    Washington D.C., District of Columbia, 20007

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain6 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Rementeria

    Madrid, 28010

  • Hospital Universitario 12 Octubre

    Madrid, 28041

  • Hospital HM Universitario Sanchinarro, CIOCC

    Madrid, 28050

Other trials in Spain

United Kingdom5 sites

  • Royal Marsden Hospital - London

    London, London, CITY of, SW3 6JJ

  • Royal Marsden Hospital NHS Foundation Trust

    London, SW3 6JJ

  • Royal Marsden Hospital -Fulham Road

    London, SW36JJ

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

  • Royal Marsden Hospital NHS Foundation Trust

    Surrey, Sutton, SM2 5PT

Other trials in United Kingdom

Belgium3 sites

  • UZ Leuven - Dermatology

    Leuven, 3000

  • UZ Leuven - Ophthalmology

    Leuven, 3000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Netherlands3 sites

  • The Netherlands Cancer Institute Antoni Van Leeuwenhoek

    Amsterdam, North Holland, 1066 CX

  • OLVG locatie Oost

    Amsterdam, North Holland, 1091 AC

  • Amsterdam Medical Center (AMC)

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation

This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at least one prior line of therapy and no more than 2 prior lines of therapy. The study contains a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the efficacy of the combinations.

Being tested
binimetinib, nivolumab, ipilimumab
Keywords
cancer
Medical subject headings
Neoplasms

What participants receive

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

  • binimetinibDrug

    Orally, twice daily.

  • nivolumabDrug

    Intravenously (IV) every 4 weeks (Q4W)

  • ipilimumabDrug

    intravenously (IV) every 8 weeks (Q8W)

Study groups in NCT03271047
Study groupRoleWhat they receive
Phase 1b / Arm 1AExperimentalbinimetinib + nivolumab
Receives: Drug: binimetinib; Drug: nivolumab
Phase 1b / Arm 1BExperimentalbinimetinib + nivolumab + ipilimumab
Receives: Drug: binimetinib; Drug: nivolumab; Drug: ipilimumab
Phase 2 / Arm 2AExperimentalbinimetinib + nivolumab
Receives: Drug: binimetinib; Drug: nivolumab
Phase 2 / Arm 2BExperimentalbinimetinib + nivolumab + ipilimumab
Receives: Drug: binimetinib; Drug: nivolumab; Drug: ipilimumab

What is being measured

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

  1. Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)

    DLT:Adverse event(AE)/abnormal laboratory assessed unrelated-disease,disease progression,intercurrent illness/concomitant medication/therapies resulting inability tolerate 75% dose intensity in Cycle 1.Total bilirubin(TBL)grade(G)>=3 (>3.0*upper limit of normal[ULN)]);AST/ALT>5-8*ULN>5 days,>8*ULN,>3*ULN concurrent TBL>2*ULN;G>=3 serum creatinine,CK elevation,ECG QTcF prolonged,G3 troponin,electrolyte>72 hours,G3/4 amylase/lipase.G4 ANC,platelet count>7 days;G3/4 platelet count,other AE except lymphopenia.G>=3 retinopathy,other disorder>21 days;G2 uveitis/eye pain/blurred vision/decreased visual acuity;G4 other disorder.Decrease LVEF>10% G>=3 cardiac disorders.G3/4 hypertension.G3 fatigue>=7 days,hypersensitivity,infusion reaction,fever>=72 hours/hemodynamic compromise,endocrinopathy.G>=2 interstitial lung disease/pneumonitis;G3 bronchospasm.G3/4 rash,hand foot skin reaction,photosensitivity.G3 colitis;G3/4 diarrhea,nausea/vomiting.Neurologic G3.Other hematologic/nonhematolic G>=3 AE.

    Measured: Cycle 1: Day 1 up to Day 28

  2. Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

    ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<)10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to 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 considered progression.

    Measured: From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 2: maximum up to 26 months approximately)

Secondary outcomes (10)

  1. Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1

    ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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.

    Measured: From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately)

  2. Duration of Response (DOR) as Per RECIST v1.1

    DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.

    Measured: From date of first documented CR/PR to date of first documented PD, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately, Phase 2: maximum up to 26 months approximately)

  3. Percentage of Participants With Complete Response as Per RECIST v1.1

    Complete response as per RECIST v1.1 was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm.

    Measured: From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately)

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03

    AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs: events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy minus 1 day, whichever occurred first. TEAE graded by CTCAE grade 4.03: Grade 3: severe/medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care activities of daily living (ADL); Grade 4: life-threatening consequence, urgent intervention indicated. In this outcome measure, number of participants with 'all grades' and 'Grade 3/4' were reported.

    Measured: From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately)

  5. Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation

    Hematological parameters included: Hemoglobin graded high, Hemoglobin graded low, Platelets count graded low, White Blood Cell (WBC) graded high, WBC graded low, Neutrophils graded low, Lymphocytes graded high, Lymphocytes graded low. Coagulation parameters included: International Normalized Ratio (INR) graded high, Activated Partial Thromboplastin Time (aPTT) graded high. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded >=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported.

    Measured: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)

  6. Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation

    Hematology parameters: Basophils, Eosinophils, Hematocrit, Monocytes, Red blood cells (RBC). Coagulation parameters: Prothrombin Time. Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Laboratory parameters were graded based on laboratory normal ranges as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported.

    Measured: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)

  7. Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry

    Abnormalities: Albumin graded low, Alkaline phosphatase (ALP) graded high, Alanine aminotransferase (ALT) graded high, Aspartate aminotransferase (AST) graded high, Bilirubin graded high, Amylase graded high, Creatinine graded high, Corrected calcium graded high, Creatine Kinase (CK) graded high, Glucose graded high, Glucose graded low, Lipase graded high, Magnesium graded high, Magnesium graded low, Potassium graded high, Potassium graded low, Sodium graded high and Sodium graded low. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded >=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported.

    Measured: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)

  8. Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function

    Chemistry laboratory parameters: Blood urea nitrogen (BUN), Total protein, Chloride, Cancer antigen 19-9 (CA 19-9), Brain natriuretic peptide (BNP), Bicarbonate, Direct bilirubin, Carcinoembryonic antigen (CEA), Lactate dehydrogenase (LDH), Uric acid, Troponin I. Thyroid panel laboratory parameters: Thyroid-stimulating hormone (TSH), Free triiodothyronine (T3), Free thyroxine (T4). Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Shift in chemistry and thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported.

    Measured: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)

  9. Number of Participants With Abnormal Hepatic Laboratory Values

    Criteria for abnormal hepatic laboratory parameters: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): >3* upper limit of normal (ULN), >5*ULN, >8*ULN, >10*ULN, >20*ULN; Total bilirubin (TBL) >1.5*ULN, >2*ULN; Alkaline phosphatase (ALP) >2*ULN, >3*ULN. Categories with at least 1 non-zero data values are reported.

    Measured: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)

  10. Concentration Versus Time Summary of Plasma Concentration of Binimetinib

    Measured: 1.5 hours post dose of binimetinib on Day 1, 15 of Cycle 1; pre dose of binimetinib on Day 15 of Cycle 1, 2, 3, 4, 5

Timeline

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

  1. First posted1 Sep 2017
  2. Study start18 Oct 2017
  3. Primary completion13 Oct 2020
  4. Study completion25 Feb 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
In phase 1 it is sequential and then in phase 2 it is parallel.
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03271047
Sponsor's protocol ID
ARRAY-162-202
Other IDs
C4211004, 2017-003464-12, 2017
Status last verified
Dec 2021
First submitted
31 Aug 2017
Last updated
4 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Elez E, Cubillo A, Alfonso PG, Middleton MR, Chau I, Alkuzweny B, Alcasid A, Zhang X, Van Cutsem E. Binimetinib in combination with nivolumab or nivolumab and ipilimumab in patients with previously treated microsatellite-stable metastatic colorectal cancer with RAS mutations in an open-label phase 1b/2 study. BMC Cancer. 2024 Apr 11;24(1):446. doi: 10.1186/s12885-024-12153-5.

    PubMed 38600471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing binimetinib, nivolumab and ipilimumab in people with MSS and RAS-mutant Colorectal Cancer, run by Pfizer at 50 sites in 5 countries.

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 15 inclusion and 13 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Spain, United Kingdom, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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 Nov 2021). 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?

Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) (time frame: Cycle 1: Day 1 up to Day 28). The study lists 2 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 NCT03271047, which also lists 1 linked publication.

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 4 Jan 2022.

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