Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants With Advanced Melanoma or Renal Cell Carcinoma (MK-3475-029/KEYNOTE-29)
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ClinicalTrials.gov Identifier: NCT02089685 |
Recruitment Status :
Active, not recruiting
First Posted : March 18, 2014
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Cell Carcinoma Melanoma | Biological: Pembrolizumab Biological: PegIFN-2b Biological: Ipilimumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 293 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Clinical Trial to Study the Safety and Tolerability of MK-3475 + Pegylated Interferon Alfa-2b (PEG-IFN) and MK-3475 + Ipilimumab (IPI) in Subjects With Advanced Melanoma (MEL) and Renal Cell Carcinoma (RCC) (KEYNOTE 029) |
Actual Study Start Date : | March 17, 2014 |
Estimated Primary Completion Date : | March 11, 2021 |
Estimated Study Completion Date : | March 11, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Pembrolizumab + PegIFN-2b
Participants in Part A receive pembrolizumab intravenously (IV) at assigned dose every 3 weeks + PegIFN-2b subcutaneously (SC) at assigned dose once a week in each 6-week cycle.
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Biological: Pembrolizumab
Other Names:
Biological: PegIFN-2b Other Names:
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Experimental: Pembrolizumab + IPI Q3W
Participants in Parts 1A and 1B receive pembrolizumab IV at assigned dose every 3 weeks + IPI IV at 1 mg/kg every 3 weeks (Q3W) for a total of two 6-week cycles.
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Biological: Pembrolizumab
Other Names:
Biological: Ipilimumab Other Name: Yervoy® |
Experimental: Pembrolizumab + IPI Q6W
Participants in Part 1C receive pembrolizumab IV at assigned dose every 3 weeks + IPI IV at 50 mg every 6 weeks (Q6W) for a maximum of four 6-week cycles.
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Biological: Pembrolizumab
Other Names:
Biological: Ipilimumab Other Name: Yervoy® |
Experimental: Pembrolizumab + IPI Q12W
Participants in Part 1C receive pembrolizumab IV at assigned dose every 3 weeks + IPI IV at 100 mg every 12 weeks (Q12W) for a maximum of eight 6-week cycles.
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Biological: Pembrolizumab
Other Names:
Biological: Ipilimumab Other Name: Yervoy® |
- Number of participants with dose-limiting toxicities (Part 1A) [ Time Frame: Up to 6 weeks (Cycle 1) ]
- Number of participants experiencing adverse events (AEs) [ Time Frame: Up to 27 Months ]
- Number of participants discontinuing study drug because of AEs [ Time Frame: Up to 24 Months ]
- Progression-free survival (PFS) (Part 2) [ Time Frame: Up to 24 Months ]
- Number of participants experiencing grade 3-5 drug-related AEs (Part 1C) [ Time Frame: Up to 27 Months ]
- Objective response rate (ORR) (Part 1C) [ Time Frame: Up to 24 Months ]
- ORR using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Part 1C) [ Time Frame: Up to 24 Months ]
- ORR (Part 2) [ Time Frame: Up to 24 Months ]
- Duration of Response (DOR) (Parts 1B, 1C) [ Time Frame: Up to 24 Months ]
- Overall Survival (OS) (Parts 1B, 1C) [ Time Frame: Up to 24 Months ]
- PFS (Parts 1B, 1C) [ Time Frame: Up to 24 Months ]
- Number of participants experiencing grade 3-4 AEs [ Time Frame: Up to 27 Months ]
- ORR using RECIST 1.1 (Part 1B) [ Time Frame: Up to 24 Months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically- or cytologically-confirmed diagnosis of advanced/unresectable or metastatic MEL or RCC (Part 1A only) with predominantly clear cell elements
- Previously untreated stage III/IV advanced or metastatic MEL (Part 1C only)
- MEL subjects may be treatment naïve or may have received prior lines of therapy for metastatic disease (Parts 1A and 1B)
- RCC subjects must have received ≥1 prior line of therapy for metastatic disease (Part 1A)
- Measurable disease as defined by RECIST 1.1
- Must provide a tumor sample (archival or newly obtained biopsy) that is adequate for determination of PD (programmed cell death)-Ligand 1 status by immunohistochemistry at a central pathology laboratory prior to enrollment. Note: Adequacy of the tumor sample for PD-Ligand 1 testing is not required prior to enrollment in Part 1C
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function
- Resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (Parts 1A and 1B) and/or recovered from major surgery or radiation therapy
- Female participants of childbearing potential must be willing to use adequate contraception during the course of the study through 120 days after the last dose of study drug
- 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 drug
Exclusion Criteria
- Uveal or ocular MEL
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
- Prior therapy with an anti-programmed cell death (anti-PD)-1, anti-PD-Ligand 1, anti-PD-Ligand 2 or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a pembrolizumab clinical trial. Note: In Part 1C, participants may have received anti-PD-1 and/or anti-Cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4) as part of their neo/adjuvant treatment.
- Has received prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of trial drug or not recovered (≤ Grade 1 or at baseline) from AEs due to previously administered agents (Parts 1A and 1B)
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
- Known additional malignancy that is progressing or requires active treatment with the exception of early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer or in situ breast cancer that has undergone potentially curative therapy
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Severe hypersensitivity to any pembrolizumab excipients
- Active autoimmune disease requiring systemic treatment in the past 2 years
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Active infection requiring systemic therapy
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial from screening through 120 days after the last dose of study drug
- Prior therapy with interferon alfa (in neoadjuvant, adjuvant, or metastatic settings) (Part 1A only)
- Uncontrolled thyroid dysfunction
- Uncontrolled diabetes mellitus.
- Known history of human immunodeficiency virus (HIV)
- Known history of or is positive for Hepatitis B or Hepatitis C
- Received a live vaccine within 30 days prior to first dose of study drug

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089685
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT02089685 |
Other Study ID Numbers: |
3475-029 2013-004072-36 ( EudraCT Number ) |
First Posted: | March 18, 2014 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Melanoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas |
Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Pembrolizumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents |