Overview

This trial is active, not recruiting.

Conditions cancer, solid tumor
Treatment pembrolizumab
Phase phase 1
Target PD-1
Sponsor Merck Sharp & Dohme Corp.
Start date May 2013
End date November 2016
Trial size 297 participants
Trial identifier NCT01848834, 142453, 2012-005771-14, 3475-012

Summary

This study is being done to investigate the safety, tolerability and anti-tumor activity of pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC) (Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer (Cohort C), or advanced gastric cancer (Cohort D)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)
pembrolizumab
(Experimental)
Participants will receive pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)
pembrolizumab
(Experimental)
Participants will receive pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)
pembrolizumab
(Experimental)
Participants will receive pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)
pembrolizumab
(Experimental)
Participants will receive pembrolizumab, 200 mg, intravenously (IV) once every 3 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)
pembrolizumab

Primary Outcomes

Measure
Number of Participants Experiencing Adverse Events
time frame: Up to 90 days after last dose of study treatment (up to 2 years)
Number of Participants Discontinuing from Study Treatment Due to Adverse Events
time frame: Up to last dose of study treatment (up to 2 years)
Overall Response Evaluation Criteria in Solid Tumors version I.1 (RECIST 1.1) response rate based on Independent central radiology review (Cohort A, Cohort B HPV-negative participants, Cohort C, and Cohort D evaluated separately)
time frame: Up to 2 years
Overall RECIST 1.1 response rate based on Independent central radiology review for participants in Cohort B2
time frame: Up to 2 years

Secondary Outcomes

Measure
Overall RECIST1.1 response rate based on Independent central radiology review, Cohort B HPV-positive participants
time frame: Up to 2 years
Overall RECIST 1.1 response rate based on Independent central radiology review, Cohort D Asia-Pacific (AP) participants
time frame: Up to 2 years
Overall RECIST 1.1 Overall RECIST 1.1 response rate based on Independent central radiology review, for participants previously treated with cetuximab and platinum in Cohorts B or B2
time frame: Up to 2 years
Overall RECIST 1.1 response rate based on Investigator assessment for Cohorts A,B, C and D
time frame: Up to 2 years
Overall RECIST 1.1 response rate based on Investigator assessment for Cohort B2
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically-confirmed diagnosis of tumor that is recurrent, metastatic, or persistent: - For Cohort A - triple negative breast cancer (estrogen, progesterone, and human epidermal growth factor receptor 2 [HER2] negative) - For Cohort B - squamous cell carcinoma of the head and neck (including HPV-positive head and neck squamous cell cancer). - For Cohort C - urothelial tract cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell or non-transitional cell histology) - For Cohort D - adenocarcinoma of the stomach or gastroesophageal junction - For Cohort B2 - squamous cell carcinoma of the head and neck (both HPV-positive and -negative head and neck squamous cell cancer) - Any number of prior treatment regimens - Measurable disease - Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 - Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment - Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment Exclusion Criteria: - Currently participating in/has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment - Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment - Anti-cancer monoclonal antibody treatment within 4 weeks prior to study Day 1 or not recovered from adverse events due to agents administered more than 4 weeks earlier - Chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent - Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents - Evidence of interstitial lung disease - Active infection requiring systemic therapy - Known psychiatric or substance abuse disorders - Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment - Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody - Known history of human immunodeficiency virus (HIV) - Known active Hepatitis B or Hepatitis C - Received live vaccine within 30 days prior to start of study treatment - Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is Investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by Chair or Designee) is given allowing exception to this criterion for a specific participant

Additional Information

Official title A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors
Description Amendment 2 of the protocol added a new study arm (Cohort B2) for participants with advanced head and neck cancer who will receive a lower dose of pembrolizumab (MK-3475) every three weeks (Q3W); participants with programmed cell death ligand 1 (PD-L1)-negative tumors will also be analyzed separately.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..