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Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
EU CTIS ID: 2023-506312-41-00
What this study is testing
1. To assess the safety and tolerability of investigational treatment combinations based on the proportion of participants with adverse events (AEs) 2. 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 resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia).
- Has unresectable Stage III or Stage IV melanoma, per AJCC 8th Edition Staging Criteria, not amenable to local therapy.
- Has progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other therapies.
- Has imaging documenting progression per RECIST 1.1 and iRECIST after initiation of an anti-PD-1/L1 agent, or by RECIST 1.1 if progression occurred on adjuvant therapy or in the setting of rapid progression.
- Has not received more than 3 lines of therapy for their advanced melanoma.
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 (noninfectious) pneumonitis.
- 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.
See the full eligibility criteria
- Has histologically or cytologically confirmed melanoma.
- Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia).
- Has unresectable Stage III or Stage IV melanoma, per AJCC 8th Edition Staging Criteria, not amenable to local therapy.
- Has progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other therapies.
- Has imaging documenting progression per RECIST 1.1 and iRECIST after initiation of an anti-PD-1/L1 agent, or by RECIST 1.1 if progression occurred on adjuvant therapy or in the setting of rapid progression.
- Has not received more than 3 lines of therapy for their advanced melanoma.
- Has provided a tumor biopsy.
- Male participants who receive lenvatinib or ATRA are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or ATRA; for male participants who only receive pembrolizumab, quavonlimab, vibostolimab, or a combination, no contraception measures are needed.
- Female participant are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after the last dose of pembrolizumab, quavonlimab, vibostolimab or 30 days after the last dose of lenvatinib or ATRA, whichever occurs last.
- Has adequate organ function.
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention.
- Has a history of (noninfectious) pneumonitis.
- 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 pre-existing Grade ≥3 gastrointestinal fistula or non-gastrointestinal fistula.
- Has radiographic evidence of encasement of invasion of major blood vessel or of intratumoral cavitation.
- Has a known additional malignancy that is progressing or requires active treatment within the past 2 years.
- 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 known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has ocular or mucosal melanoma.
- Has known hypersensitivity including previous clinically significant hypersensitivity reaction to treatment with another mAb.
- 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 known history of hepatitis B.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Australia
- Switzerland
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Australia; Switzerland. 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.