Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Lin… (NCT04626479) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)
United States, Australia, Canada400 participantsStarted 2020-12-16
Plain-language summary
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC
* Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed ≥12 months before randomization/allocation.
* Is able to swallow oral medication
* Has adequate organ function
* Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before randomization/allocation
* Has resolution of toxic effects of the most recent prior therapy to ≤Grade 1
* Has adequately controlled blood pressure (BP ≤150/90 mm Hg) with no change in hypertensive medications within 1 week before randomization/allocation
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during treatment with and for at least 7 days after the last dose of lenvatinib and /or belzutifan; 7 days after lenvatinib and/or belzutifan is stopped, if the participant is only receiving pembrolizumab, pembrolizumab/quavonlimab, favezelimab/pembrolizumab or a combination of the aforementioned drugs, no contraception is needed
* Female participants must not be pregnant and not be a woman of childbearing potential (WOCBP) or is a WOCBP abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, favezelimab/pembrolizumab for 30 days after the last dose of lenvatinib or belzuti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is Phase 1/2 and is actively measuring dose-limiting toxicities and adverse events — what does that tell us about how much is still unknown about the safety of this drug combination, and how does that uncertainty compare to what we'd expect from standard first-line treatment for my kidney cancer?
2Since the trial is no longer recruiting new participants, does that mean it's closed to me entirely, or are there related studies or successor trials testing similar immune and targeted therapy combinations that might still be open?
3One of the main things this study is tracking is how often people have to stop treatment because of side effects — given my overall health and any conditions I already have, how would you assess my ability to handle a combination immunotherapy and targeted therapy regimen if those rates turn out to be significant?
4The trial is measuring objective response rate as a key efficacy outcome — at this phase of the research, do we have any early or interim data suggesting whether this combination is showing meaningful tumor shrinkage compared to approved options I could pursue right now?
5How does participating in a substudy like this one — which is part of a larger research program — affect my ability to switch to standard treatments or join other trials if this approach doesn't work for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)
Timeframe: Up to ~21 days
2
Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs)
Timeframe: Up to ~21 days
3
Safety Lead-in Phase: Number of participants who discontinue study treatment due to an AE
Timeframe: Up to ~21 days
4
Efficacy Phase: Number of participants who experience one or more DLTs
Timeframe: Up to ~21 days
5
Efficacy Phase: Number of participants who experience one or more AEs
Timeframe: Up to ~43 months
6
Efficacy Phase: Number of participants who discontinue study treatment due to an AE