Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Li… (NCT04626518) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)
United States, Australia, Canada370 participantsStarted 2020-12-17
Plain-language summary
Substudy 03B 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 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) 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
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 clear cell renal cell carcinoma (ccRCC)
* Has experienced disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with a programmed cell death ligand 1 (PD-(L)1) checkpoint inhibitor (in sequence or in combination with a vascular endothelial growth factor. - tyrosine kinase inhibitor \[VEGF-TKI\]) where PD-(L)1 checkpoint inhibitor treatment progression is defined by meeting ALL of the following criteria: (a) has received ≥2 doses of an anti-PD-(L)1 monoclonal antibody (mAb) (b) has shown radiographic disease progression during or after an anti-PD-(L)1 mAb as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by investigator (c) disease progression has been documented within 12 weeks from the last dose of an anti-PD-(L)1 mAb
* Has experienced disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with a VEGF-TKI (in sequence or in combination with a PD-\[L\]1 checkpoint inhibitor) where VEGF-TKI treatment progression is defined by meeting the following criterion: has shown radiographic disease progression during or after a treatment with a VEGF-TKI as defined by RECIST 1.1 by investigator.
* Is able to swallow oral medication
* Has adequate organ function
* Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before…
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 already active but not recruiting new patients — does that mean it's completely closed to enrollment, or are there any circumstances where I might still be considered for it?
2Since this is a Phase 1/Phase 2 trial combining immune and targeted therapies for renal cell carcinoma that has already progressed past first-line treatment, what does that early phase mean for what's currently known about the safety and effectiveness of this specific drug combination?
3The trial is specifically measuring how many people experience serious side effects serious enough to stop treatment — given what you know about my overall health, how concerned should I be about tolerating a combination immunotherapy and targeted therapy regimen?
4This trial is designed for second-line and beyond — does that mean it would be worth trying an established standard second-line treatment first, and how would that choice affect my options later?
5Are there other currently enrolling trials or approved treatments for renal cell carcinoma at my stage that you'd want me to compare against this one before making any decisions?
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 experienced DLTs
Timeframe: Up to ~21 days
5
Efficacy Phase: Number of participants who experience one or more AEs
Timeframe: Up to ~56 months
6
Efficacy Phase: Number of participants who discontinue study treatment due to an AE