EUCTR2020-005628-12-IT
Active, not recruiting
Phase 1
A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination with Investigational Agents for the Treatment of Participants With PD-1/L1- refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98) - Phase 1b/2 Second-Line ES-SCLC Platform Study
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites80 target enrollmentJuly 9, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Sponsor
- MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Has histologically or cytologically confirmed diagnosis of ES\-SCLC in need of second\-line therapy
- •2\. Participants must have progressed on or after treatment with an anti\- PD\-1/L1 mAb administered as part of first\-line platinum\-based systemic
- •therapy for ES\-SCLC. PD\-1/L1 checkpoint inhibitor treatment progression is defined by meeting ALL of the following criteria:
- •a. Has received at least 2 doses of an anti\-PD\-1/L1 mAb
- •b. Has demonstrated radiographic disease progression during or after an anti\-PD\-1/L1 mAb as defined by investigator
- •c. Disease progression has been documented within 12 weeks from the last dose of an anti\-PD\-1/L1 mAb
- •3\. Has extensive\-stage SCLC defined as Stage IV by the American Joint Committee on Cancer, Eighth Edition
- •4\. Has received 1 prior line of systemic therapy for SCLC. Study intervention will treat second\-line ES\-SCLC
- •5\. Is male or female, at least 18 years of age at the time of providing documented informed consent
- •6\. Male participants are eligible to participate if they 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. The length of time required to continue contraception for
Exclusion Criteria
- •1\. Has had major surgery within 3 weeks before first dose of study interventions
- •2\. Has a preexisting \=Grade 3 gastrointestinal or non\-gastrointestinal fistula
- •3\. Has urine protein \=1 g/24 hours
- •4\. Has a LVEF below the institutional (or local laboratory) normal range, as determined by MUGA or ECHO
- •5\. Prolongation of QTcF interval to \>480 ms
- •6\. Has clinically significant cardiovascular disease or major arterial thromboembolic event within 12 months before first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- •7\. Has active hemoptysis (bright red blood of at least 0\.5 teaspoon) within 3 weeks before the first dose of study intervention
- •8\. Has gastrointestinal malabsorption or any other condition that might affect oral study intervention absorption
- •9\. Has serious nonhealing wound, ulcer, or bone fracture within 28 days before the start of study intervention
- •10\. Has any major hemorrhage or venous thromboembolic events within 3 months before the start of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the start of study intervention must be on stable doses of anticoagulants
Outcomes
Primary Outcomes
Not specified
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