Informations générales (source: ClinicalTrials.gov)
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants
Interventional
Phase 1/Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
décembre 2020
mai 2026
05 avril 2025
Substudy 03A 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 03A is to evaluate the safety and efficacy of experimental
combinations of investigational agents in participants with advanced first line (1L)
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Laurence ALBIGES | 28/05/2024 10:23:11 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Claudius Regaud ( Site 1200) - 31059 - Toulouse Cedex 9 - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
| Institut De Cancerologie De Lorraine ( Site 1204) - 54519 - Vandoeuvre les Nancy - Ain - France | Contact (sur clinicalTrials) | ||||
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203) - 67200 - Strasbourg - Alsace - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC
- Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant
therapy for RCC is acceptable if completed ≥12 months before
randomization/allocation.
- 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
- 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,
favezelimab/pembrolizumab or a combination of the aforementioned drugs, no
contraception is needed
- Female participants must not be pregnant and not be 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, favezelimab/pembrolizumab for
30 days after the last dose of lenvatinib or belzutifan, whichever occurs last and
must abstain from breastfeeding during the study intervention period and for at
least 120 days after study intervention
- Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC
- Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant
therapy for RCC is acceptable if completed ≥12 months before
randomization/allocation.
- 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
- 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,
favezelimab/pembrolizumab or a combination of the aforementioned drugs, no
contraception is needed
- Female participants must not be pregnant and not be 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, favezelimab/pembrolizumab for
30 days after the last dose of lenvatinib or belzutifan, whichever occurs last and
must abstain from breastfeeding during the study intervention period and for at
least 120 days after study intervention
- Has urine protein ≥1 g/24 hours and has any of the following: (a) a pulse oximeter
reading <92% at rest, or (b) requires intermittent supplemental oxygen, or (c)
requires chronic supplemental oxygen (d) active hemoptysis within 3 weeks prior to
the first dose of study intervention
- 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 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 drug; 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