Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrol… (NCT04938817) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
United States, Australia, Austria110 participantsStarted 2021-08-19
Plain-language summary
This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation.
Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D.
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:
The main inclusion criteria include but are not limited to the following:
* Arms A-E:
* Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy
* Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered as part of first-line platinum-based systemic therapy for ES-SCLC
* Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
* Has received 1 prior line of systemic therapy for small cell lung cancer (SCLC)
* If a woman of childbearing potential (WOCBP), participant must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study treatment
* Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by BICR
* Has submitted an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before allocation/randomization
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Parti…
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 in Phase 1/2 and is actively measuring how many people experience serious side effects or have to stop treatment because of them — what does that tell us about how much is still unknown about the safety of these drug combinations?
2The trial combines investigational agents with pembrolizumab as a second-line therapy for extensive-stage small cell lung cancer — given where I am in my treatment journey, would I even be a candidate to be considered for something like this, or should I be looking at other second-line options first?
3Since the trial is no longer recruiting new participants, does that mean I've missed the window to potentially enroll, and are there similar studies or successor trials you'd recommend I look into instead?
4One of the main things this study is measuring is objective response rate using RECIST 1.1 criteria — can you explain in plain terms what that means, and how meaningful a tumor response in a trial like this would actually be for someone in my situation?
5Given that this is a Phase 1/2 study still gathering basic safety data, how would you weigh the potential risks of an investigational combination treatment against sticking with a more established second-line approach for my specific case?
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
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Timeframe: Up to 21 days in Cycle 1 (Cycle 1 = 21 days)
2
Number of Participants Who Experience at Least One Adverse Event (AE)
Timeframe: Up to approximately 60 months
3
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timeframe: Up to approximately 60 months
4
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)