Clinical trial • Phase I/II|Phase II • Oncology
PEMBROLIZUMAB for Renal cell carcinoma
Phase I/II|Phase II trial of PEMBROLIZUMAB for Renal cell carcinoma. Randomised, adaptive. 194 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Renal cell carcinoma
- Trial Stage
- Phase I/II|Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 12-12-2023
- First CTIS Authorization Date
- 22-01-2024
Trial design
Randomised, adaptive Phase I/II|Phase II trial in Netherlands, Spain, Poland and others.
- Randomised
- Yes
- Adaptive
- True, Safety lead-in phase to assess safety/tolerability and to establish a Recommended Phase 2 Dose (RP2D) if applicable; the design includes a safety lead-in (dose-finding) followed by an efficacy phase.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 194
Eligibility
Recruits 194 Vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent is required from participants; subject information and informed consent forms are listed in the documentation (multiple language versions present). No specific assent or additional vulnerable-population consent procedures are described in the record..
- Pregnancy Exclusion
- 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, and vibostolimab/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
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent is required from participants; subject information and informed consent forms are listed in the documentation (multiple language versions present). No specific assent or additional vulnerable-population consent procedures are described in the record.
Inclusion criteria
- {"criterion_text":"- Has a histologically confirmed diagnosis of locally advanced/metastatic clear cell renal cell carcinoma (ccRCC)\n- Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed ≥12 months before randomization/allocation.\n- Is able to swallow oral medication\n- Has adequate organ function\n- Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before randomization/allocation\n- Has resolution of toxic effects of the most recent prior therapy to ≤Grade 1\n- Has adequately controlled blood pressure (BP ≤150/90 mm Hg) with no change in hypertensive medications within 1 week before randomization/allocation\n- 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, vibostolimab/pembrolizumab or a combination of the aforementioned drugs, no contraception is needed\n- 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, and vibostolimab/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"}
Exclusion criteria
- {"criterion_text":"- 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\n- Has received more than 4 previous systemic anticancer treatment regimens\n- Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n- Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis\n- 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\n- Has an active infection requiring systemic therapy\n- Has a known history of human immunodeficiency virus (HIV) infection\n- Has a known history of Hepatitis B\n- Has had an allogenic tissue/solid organ transplant\n- Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention administration\n- Has had major surgery within 3 weeks before first dose of study interventions\n- Has a history of lung disease\n- Has a history of inflammatory bowel disease\n- Has preexisting gastrointestinal (GI) or non-GI fistula\n- Has malabsorption due to prior GI surgery or disease\n- Has received prior radiotherapy within 2 weeks of start of study intervention\n- Has received a live or live attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed"}
Endpoints
Primary endpoints
- {"endpoint_text":"- afety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)","definition_or_measurement_approach":"Count of participants experiencing one or more dose-limiting toxicities observed during the Safety Lead-in Phase."}
- {"endpoint_text":"- Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs)","definition_or_measurement_approach":"Count of participants experiencing one or more adverse events during the Safety Lead-in Phase."}
- {"endpoint_text":"- Safety Lead-in Phase: Number of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment as a result of an adverse event during the Safety Lead-in Phase."}
- {"endpoint_text":"- Efficacy Phase: Number of participants who experience one or more DLTs","definition_or_measurement_approach":"Count of participants experiencing one or more dose-limiting toxicities during the Efficacy Phase."}
- {"endpoint_text":"- Efficacy Phase: Number of participants who experience one or more AEs","definition_or_measurement_approach":"Count of participants experiencing one or more adverse events during the Efficacy Phase."}
- {"endpoint_text":"- Efficacy Phase: Number of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment because of an adverse event during the Efficacy Phase."}
- {"endpoint_text":"- Efficacy Phase: Objective response rate (ORR)","definition_or_measurement_approach":"Objective response rate assessed per RECIST 1.1."}
Secondary endpoints
- {"endpoint_text":"- Efficacy Phase: Duration of response (DOR)","definition_or_measurement_approach":"Duration of response measured per RECIST 1.1."}
- {"endpoint_text":"- Efficacy Phase: Progression-free survival (PFS)","definition_or_measurement_approach":"Progression-free survival assessed per RECIST 1.1."}
- {"endpoint_text":"- Efficacy Phase: Overall survival (OS)","definition_or_measurement_approach":"Overall survival (time from randomization/allocation to death from any cause)."}
- {"endpoint_text":"- Efficacy Phase: Clinical benefit rate (CBR)","definition_or_measurement_approach":"Clinical benefit rate assessed per RECIST 1.1."}
Recruitment
- Planned Sample Size
- 194
- Recruitment Window Months
- 65
- Consent Approach
- Informed consent is required from participants. Subject information and informed consent form (L1_ICF) documents are listed for multiple countries/languages (e.g. Spain, Poland, Hungary, France). No specific assent procedures or additional vulnerable-population consent procedures are described in the record.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 62
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 11-09-2024
- Processing Time Days
- 252
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- Koen van der Mijn
- Contact Person Email
- k.vd.mijn@nki.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Astrid van der Veldt
- Contact Person Email
- a.vanderVeldt@Erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Medical Oncology
- Contact Person Name
- Britt Suelmann
- Contact Person Email
- oncostudies@umcutrecht.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 819
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology Department
- Contact Person Name
- Pablo Gajate Borau
- Contact Person Email
- pgajateborau@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology Department
- Contact Person Name
- Cristina Suarez Rodriguez
- Contact Person Email
- csuarez@vhio.net
Poland
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 821
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Klinicznych Wczesnych Faz
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- obkwf@uck.gda.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium chemioterapii
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- badania.kliniczne@co.bydgoszcz.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 818
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Gyógszerterápiás Központ, Urogenitális Tumorok és Klinikai Farmakológiai Osztály, Kemoterápia C”
- Contact Person Name
- Lajos Géczi
- Contact Person Email
- geczi.lajos@oncol.hu
France
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 855
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Medical Oncology
- Contact Person Name
- Barthelemy Philippe
- Contact Person Email
- philippe.barthelemy@chru-strasbourg.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Département d'oncologie médicale
- Contact Person Name
- Sophie Martin
- Contact Person Email
- so.martin@nancy.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d’Oncologie Médicale
- Contact Person Name
- Laurence ALBIGES
- Contact Person Email
- laurence.albiges@gustaveroussy.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Not applicable
- Contact Person Name
- Carlos Alberto Gomez Roca
- Contact Person Email
- gomez-roca.carlos@iuct-oncopole.fr
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Global Central Labs
- Responsibilities
- code:4
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- code:3
- Name
- PRA International
- Responsibilities
- Central imaging
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
Third parties
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PRA International","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 2
- Investigational Product Name
- MK-7684A
- Active Substance
- PEMBROLIZUMAB, VIBOSTOLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 1
- Investigational Product Name
- MK-1308A
- Active Substance
- PEMBROLIZUMAB, QUAVONLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 1
- Investigational Product Name
- Belzutifan
- Active Substance
- BELZUTIFAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 1
- Investigational Product Name
- MK-4280A
- Active Substance
- PEMBROLIZUMAB, FAVEZELIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- 1
- Investigational Product Name
- Lenvatinib
- Active Substance
- LENVATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 1
- Combination Treatment
- Yes
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