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Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants with Melanoma (KEYMAKER-U02): Substudy 02B
EU CTIS ID: 2023-506313-21-00
What this study is testing
1. Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study. 2. To assess the safety and tolerability of investigational treatment combinations based on the proportion of participants with adverse events (AEs) 3. To evaluate objective response rate (ORR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has histologically or cytologically confirmed melanoma
- Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
- Has been untreated for advanced disease.
- Has provided a tumor biopsy
- If capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (7 days): • Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Uses contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP OR • Is a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is: o MK-4280A: 120 days o MK-1308A: 120 days o MK-7684: 50 days o MK-3475: 120 days o Lenvatinib: 30 days o ATRA: 30 days
You likely can't join if
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
- Has a history of active tuberculosis (TB)
- Has received prior systemic anticancer therapy within 4 weeks prior to randomization
- Has received prior radiotherapy within 2 weeks of first dose of study intervention
- Has had major surgery <3 weeks prior to first dose of study intervention
- Has received a live vaccine within 30 days before the first dose of study intervention
See the full eligibility criteria
- Has histologically or cytologically confirmed melanoma
- Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
- Has been untreated for advanced disease.
- Has provided a tumor biopsy
- If capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (7 days): • Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Uses contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP OR • Is a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is: o MK-4280A: 120 days o MK-1308A: 120 days o MK-7684: 50 days o MK-3475: 120 days o Lenvatinib: 30 days o ATRA: 30 days
- Has adequate organ function
- Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy)
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
- Has a history of active tuberculosis (TB)
- Has received prior systemic anticancer therapy within 4 weeks prior to randomization
- Has received prior radiotherapy within 2 weeks of first dose of study intervention
- Has had major surgery <3 weeks prior to first dose of study intervention
- Has received a live vaccine within 30 days before the first dose of study intervention
- Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention
- Has had an allogeneic tissue/solid organ transplant
- Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
- Participants who receive lenvatinib have the following additional exclusion criteria: • Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula • Has radiographic evidence of encasement of invasion of a major blood vessel, or of intratumoral cavitation • Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study intervention • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention • Has urine protein ≥1 g/24-hour. • Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
- Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has ocular or mucosal melanoma
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has an active infection requiring systemic therapy
- Has known history of human immunodeficiency virus (HIV)
- Has history of Hepatitis B or known Hepatitis C virus infection
- Has a history of (noninfectious) pneumonitis
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Chile
- Australia
- Colombia
- Switzerland
- South Africa
- Argentina
- Israel
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Chile; Australia; Colombia; Switzerland; South Africa and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.