Advanced CancerPhase 1/2PembroMabNCT02318901
Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer
A Phase 1/2 study testing Pembrolizumab, Trastuzumab and ado-trastuzumab emtansine in people with Advanced Cancer and Breast Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will be for patients with HER2 overexpressing metastatic breast cancer (MBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Breast Cancer, Gastric Cancer
- What is being tested?
- Pembrolizumab, Trastuzumab and ado-trastuzumab emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2018
- 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
- Patient has definitive histologically or cytologically confirmed unresectable or metastatic solid tumor.
- Patient has one or more tumor measurable as defined by RECIST 1.1 by CT scan (or PET/CT, if patient is allergic to CT contrast media).
- Patients can be enrolled only on one of the treatment arms on this trial.
- The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance to a specific Mab and then enrolled on an arm with that same Mab plus pembro, (b) The Mab on the arm selected must be considered standard of care or listed in the NCCN guidelines (www.nccn.org) for that cancer type. For Arm 1, patients with HER2 overexpressing MBC eligible for maintenance trastuzumab are allowed after taxane plus trastuzumab plus pertuzumab combination therapy.
- Have recovered from acute toxicities of prior treatment:
- > 3 weeks must have elapsed since receiving any investigational agent.
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- > 2 weeks must have elapsed since receiving any radiotherapy, or ≥ 3 weeks or 5 half-lives whichever is shorter for treatment with cytotoxic or biologic agents ( ≥ 6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
- Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening:
- Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 9 g/dL.
- Serum creatinine ≤2.0, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal (ULN) range
- Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the upper limit of normal range, then a free T4 within institutional normal limits is acceptable.
- Persistent prior systemic therapy non-hematologic AE grade ≥ 2 (except alopecia or correctable electrolyte abnormality with supplementation)
- Patient has a Karnofsky performance status (KPS) ≥ 70.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
- Patients must have unresectable HER2 overexpressing gastric or GEJ cancers to be enrolled on Cohort 1 of the pembro plus trastuzumab phase II portion.
- Patients must have HER2 overexpressing MBC to be enrolled on Cohort 2 of the pembro plus trastuzumab phase II portion.
- Patients must have HER2 overexpressing MBC to be enrolled on pembro plus ado-trastuzumab emtansine phase II portion.
- Patients must have HNSCC to be enrolled on Cohort 1 of the pembro plus cetuximab phase II portion.
- Patients must have K-ras, B-raf, N-ras wildtype CRC to be enrolled on Cohort 2 of the pembro plus cetuximab phase II portion.
Who cannot join
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
- Requiring daily corticosteroid dose ≥ 10 mg prednisone or equivalent per day.
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- Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindication or Special Warnings and Precautions sections of the product or comparator SmPC or Prescribing Information.
- Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Patient will be receiving any other anti-cancer therapy during participation in this trial.
- Prior treatment with pembro. Receipt of other PD-1 inhibitors or PD-L1 inhibitors is allowed.
- Active or prior documented autoimmune disease requiring systemic treatment within the past 2 years.
- 1. Patients with a history of more than one primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the 2 years prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Regional Medical Center/Cancer Treatment Center of America
Goodyear, Arizona, 85338
About this study
Official title: A Phase Ib/II Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer (PembroMab
There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC. There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype metastatic CRC.
Read the detailed description
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Pembrolizumab will be infused prior to the start of the assigned monoclonal antibody (Mab) arm. .
Dosing for the Mab arms will begin as follows:
Arm 1: Cycle length is 21 days. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.
Arm 2: Cycle length is 21 days. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.
Arm 3: Cycle length is 21 days. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.
- Being tested
- Pembrolizumab, Trastuzumab, ado-trastuzumab emtansine, Cetuximab
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA
TrastuzumabDrug
Also called Herceptin
ado-trastuzumab emtansineDrug
Also called Kadcyla
CetuximabDrug
Also called Erbitux
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days. Receives: Drug: Pembrolizumab; Drug: Trastuzumab |
| Arm 2 | Experimental | Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days. Receives: Drug: Pembrolizumab; Drug: ado-trastuzumab emtansine |
| Arm 3 | Experimental | Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days. Receives: Drug: Pembrolizumab; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Recommended Phase 2 Dose (RP2D) of Monoclonal Antibody Therapy (Mab) in Combination With Pembrolizumab (Pembro) in Subjects With Advanced Cancer
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
Measured: 3 weeks
Secondary outcomes (5)
Frequency of Grade 3 or Higher Treatment-related Adverse Events by CTCAE 4.03
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
Measured: up to 12 months
Response Rate by irRC and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
Measured: 12 weeks
To Determine the Overall Survival (OS) and Progression-free Survival (PFS)
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
Measured: up to 12 months
To Characterize Changes in Circulating Tumor DNA in Patients Enrolled on This Study
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
Measured: up to 12 months
Textural Changes Identified on Imaging That is Done Per Routine Practice
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: PI no longer at sight. Results not collected
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.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Waypa, FNP, Study director, Western Regional Medical CenterAlan Tan, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318901
- Sponsor's protocol ID
- PembroMab
- Acronym
- PembroMab
- Status last verified
- Oct 2019
- First submitted
- 8 Dec 2014
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer (PembroMab
- ClinicalTrials.gov ID
- NCT02318901
- Acronym / sponsor ID
- PembroMab / PembroMab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI no longer at sight. Results not collected
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC. There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype metastatic CRC.
Detailed description
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Pembrolizumab will be infused prior to the start of the assigned monoclonal antibody (Mab) arm. .
Dosing for the Mab arms will begin as follows:
Arm 1: Cycle length is 21 days. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days.
Arm 2: Cycle length is 21 days. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days.
Arm 3: Cycle length is 21 days. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Pembrolizumab, Drug: TrastuzumabPembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days. |
| Arm 2 | Experimental | Drug: Pembrolizumab, Drug: ado-trastuzumab emtansinePembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days. |
| Arm 3 | Experimental | Drug: Pembrolizumab, Drug: CetuximabPembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient has definitive histologically or cytologically confirmed unresectable or metastatic solid tumor.
- Patient has one or more tumor measurable as defined by RECIST 1.1 by CT scan (or PET/CT, if patient is allergic to CT contrast media).
- Patients can be enrolled only on one of the treatment arms on this trial.
- The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance to a specific Mab and then enrolled on an arm with that same Mab plus pembro, (b) The Mab on the arm selected must be considered standard of care or listed in the NCCN guidelines (www.nccn.org) for that cancer type. For Arm 1, patients with HER2 overexpressing MBC eligible for maintenance trastuzumab are allowed after taxane plus trastuzumab plus pertuzumab combination therapy.
- Have recovered from acute toxicities of prior treatment:
Key exclusion criteria (13 listed)
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
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: KEYTRUDA | Drug | Arm 1, Arm 2, Arm 3 |
| TrastuzumabAlso: Herceptin | Drug | Arm 1 |
| ado-trastuzumab emtansineAlso: Kadcyla | Drug | Arm 2 |
| CetuximabAlso: Erbitux | Drug | Arm 3 |
Primary outcome
Determine the Recommended Phase 2 Dose (RP2D) of Monoclonal Antibody Therapy (Mab) in Combination With Pembrolizumab (Pembro) in Subjects With Advanced Cancer
Time frame: 3 weeks
PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.
5 secondary outcomes
Frequency of Grade 3 or Higher Treatment-related Adverse Events by CTCAE 4.03
Time frame: up to 12 months
Response Rate by irRC and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
Time frame: 12 weeks
To Determine the Overall Survival (OS) and Progression-free Survival (PFS)
Time frame: up to 12 months
To Characterize Changes in Circulating Tumor DNA in Patients Enrolled on This Study
Time frame: up to 12 months
Textural Changes Identified on Imaging That is Done Per Routine Practice
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jordan Waypa, FNP study director
Western Regional Medical Center
Alan Tan, MD principal investigator
Western Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab, Trastuzumab and ado-trastuzumab emtansine in people with Advanced Cancer and Breast Cancer, run by Western Regional Medical Center at 1 site in United States.
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 19 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: stopped early, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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 Nov 2018). 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?
Determine the Recommended Phase 2 Dose (RP2D) of Monoclonal Antibody Therapy (Mab) in Combination With Pembrolizumab (Pembro) in Subjects With Advanced Cancer (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2019.