Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.
Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.
Intervention / Treatment
- Drug: Pembrolizumab
- Drug: Standard of Care (SOC)
- Drug: Lenvatinib
- Drug: Olaparib
- Drug: MK-4280
- Biological: MK-4280A
Inclusion Criteria:
- Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
- Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.
Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
- Has not received any anticancer systemic treatment since the last dosethe amount of medication taken of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
- Has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- Demonstrates adequate organ function.
- Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1 or less (except alopeciathe partial or complete absence of hair from areas of the body where it normally grows; baldness) before trial treatment in Second Course Phase is started. If participant received major surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence or radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
- A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with riskthe possibility that something bad will happen of genotoxicity.
Additional eligibility criteria for participants who enter dosing with Lenvatinib:
- Adequately controlled bloodthe red bodily fluid that transports oxygen and other nutrients around the body pressure (BP) to <150/90 mmHg, with or without antihypertensive medications.
- For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
- Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.