Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

  • STATUS
    Recruiting
  • End date
    Jan 15, 2024
  • participants needed
    370
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 12 May 2021

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.

Details
Condition Renal Cell Carcinoma, Renal Cell Cancer
Treatment Pembrolizumab, Lenvatinib, MK-4280, MK-4830, Belzutifan, Quavonlimab
Clinical Study IdentifierNCT04626518
SponsorMerck Sharp & Dohme Corp.
Last Modified on12 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Is your age between 18 yrs and 120 yrs?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Gender: Male or Female
Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC
Has experienced disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with a 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 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 randomization/allocation
Has resolution of toxic effects of the most recent prior therapy to Grade 1
If participants receive major surgery or radiation therapy, they must have recovered from complications from the intervention
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, MK-4280A, MK-4830 or a combination of the aforementioned drugs, no contraception is needed
Female participant is not pregnant or breastfeeding and is not 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, MK-4280A, MK-4830 or 30 days after the last dose of lenvatinib or belzutifan, whichever occurs last

Exclusion Criteria

Has urine protein 1 g/24 hours and has any of the following: (a) hypoxia defined as a pulse oximeter reading <92% at rest, or (b) requires intermittent supplemental oxygen, or (c) requires chronic supplemental oxygen
Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention administration
Has had major surgery within 3 weeks before first dose of study interventions
Has a history of lung disease
Has a history of inflammatory bowel disease
Has preexisting gastrointestinal (GI) or non-GI fistula
Has malabsorption due to prior GI surgery or disease
Has previously received treatment with a combination of pembrolizumab plus lenvatinib
Has received prior treatment with belzutifan
Has received prior radiotherapy within 2 weeks of start of study intervention
Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; killed vaccines are allowed
Has received more than 4 previous systemic anticancer treatment regimens
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B
Has had an allogenic tissue/solid organ transplant
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