## Protocol Section
### Identification Module
**NCT ID:** NCT04626479

**Brief Title:** Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

**Official Title:** A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A

#### Organization Study ID Info
**ID:** 3475-03A
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-3475-03A
**Type:** OTHER
**Domain:** EU CT
**ID:** 2023-506838-68-00
**Type:** REGISTRY
**ID:** 2019-003609-84
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2026-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-18

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-17

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2026-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-12-16

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2020-11-12
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-10
**Study First Submit QC Date:** 2020-11-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Carcinoma, Renal Cell

**Keywords:**

- receptor tyrosine kinase inhibitor

- programmed cell death 1 (PD-1, PD1)

- programmed cell death ligand 1 (PD-L1, PDL1)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \~2 years). Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation.

**Intervention Names:**

- Drug: Lenvatinib

- Biological: Pembrolizumab/Quavonlimab

**Label:** Coformulation Pembrolizumab/Quavonlimab + Lenvatinib

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) PLUS lenvatinib 20 mg. Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.

**Intervention Names:**

- Biological: Favezelimab/Pembrolizumab

- Drug: Lenvatinib

**Label:** Coformulation Favezelimab/Pembrolizumab+ Lenvatinib

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~2 years). Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.

**Intervention Names:**

- Biological: Pembrolizumab

- Drug: Belzutifan

- Drug: Lenvatinib

**Label:** Pembrolizumab + Belzutifan + Lenvatinib

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~ 2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.

**Intervention Names:**

- Biological: Pembrolizumab

- Drug: Lenvatinib

**Label:** Pembrolizumab + Lenvatinib

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Participants will receive vibostolimab/pembrolizumab (coformulation of 200 mg vibostolimab and pembrolizumab 200 mg). Vibostolimab/pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Belzutifan will be administered orally QD until progressive disease or discontinuation.

**Intervention Names:**

- Drug: Belzutifan

- Drug: Vibostolimab/Pembrolizumab

**Label:** Coformulation Vibostolimab/Pembrolizumab+Belzutifan

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pembrolizumab + Belzutifan + Lenvatinib

- Pembrolizumab + Lenvatinib

**Description:** Administered via IV infusion at a dose of 400 mg Q6W

**Name:** Pembrolizumab

**Other Names:**

- MK-3475

- KEYTRUDA®

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Coformulation Favezelimab/Pembrolizumab+ Lenvatinib

**Description:** Administered via IV infusion at a dose of 800 mg/200 mg Q3W

**Name:** Favezelimab/Pembrolizumab

**Other Names:**

- MK-4280A

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Coformulation Vibostolimab/Pembrolizumab+Belzutifan

- Pembrolizumab + Belzutifan + Lenvatinib

**Description:** Administered via oral tablet at a dose of 120 mg QD

**Name:** Belzutifan

**Other Names:**

- MK-6482

- WELIREG™

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Coformulation Favezelimab/Pembrolizumab+ Lenvatinib

- Coformulation Pembrolizumab/Quavonlimab + Lenvatinib

- Pembrolizumab + Belzutifan + Lenvatinib

- Pembrolizumab + Lenvatinib

**Description:** Administered via oral capsule at a dose of 20 mg QD

**Name:** Lenvatinib

**Other Names:**

- MK-7902

- E7080

- LENVIMA®

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Coformulation Pembrolizumab/Quavonlimab + Lenvatinib

**Description:** Administered via IV infusion at a dose of 400 mg/25 mg Q6W

**Name:** Pembrolizumab/Quavonlimab

**Other Names:**

- MK-1308A

**Type:** BIOLOGICAL

#### Intervention 6

**Arm Group Labels:**

- Coformulation Vibostolimab/Pembrolizumab+Belzutifan

**Description:** Administered via IV infusion at a dose of 200 mg/200 mg Q6W

**Name:** Vibostolimab/Pembrolizumab

**Other Names:**

- MK-7684A

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting \>7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalization or persists for \>1 week (5) gr 3 or 4 febrile neutropenia (6) gr 3 or 4 alanine aminotransferase, aspartate aminotransferase and/or bilirubin laboratory value (7) treatment related adverse event (AE) causing study intervention discontinuation during the first 21 days (8) treatment related AE causing intervention administration delay for \>14 days during the first 21 days (9) gr 5 toxicity. The number of participants who experience one or more DLTs in the safety lead-in phase will be presented.

**Measure:** Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)

**Time Frame:** Up to ~21 days

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs in the safety lead-in phase will be presented.

**Measure:** Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs)

**Time Frame:** Up to ~21 days

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE in the safety lead-in phase will be presented.

**Measure:** Safety Lead-in Phase: Number of participants who discontinue study treatment due to an AE

**Time Frame:** Up to ~21 days

**Description:** DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting \>7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalization or persists for \>1 week (5) gr 3 or 4 febrile neutropenia (6) gr 3 or 4 alanine aminotransferase, aspartate aminotransferase and/or bilirubin laboratory value (7) treatment related adverse event (AE) causing study intervention discontinuation during the first 21 days (8) treatment related AE causing intervention administration delay for \>14 days during the first 21 days (9) gr 5 toxicity. The number of participants who experience one or more DLTs in the efficacy phase will be presented.

**Measure:** Efficacy Phase: Number of participants who experience one or more DLTs

**Time Frame:** Up to ~21 days

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs in the efficacy phase will be presented.

**Measure:** Efficacy Phase: Number of participants who experience one or more AEs

**Time Frame:** Up to ~43 months

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE in the efficacy phase will be presented.

**Measure:** Efficacy Phase: Number of participants who discontinue study treatment due to an AE

**Time Frame:** Up to ~43 months

**Description:** ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

**Measure:** Efficacy Phase: Objective response rate (ORR)

**Time Frame:** Up to ~43 months

#### Secondary Outcomes

**Description:** For participants in the analysis population who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), DOR is defined as the time from first documented evidence of CR or PR until progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 by BICR.

**Measure:** Efficacy Phase: Duration of response (DOR)

**Time Frame:** Up to ~43 months

**Description:** PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 by BICR.

**Measure:** Efficacy Phase: Progression-free survival (PFS)

**Time Frame:** Up to ~43 months

**Description:** OS is defined as the time from randomization to death due to any cause.

**Measure:** Efficacy Phase: Overall survival (OS)

**Time Frame:** Up to ~43 months

**Description:** CBR is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) of ≥6 months. Responses are according to RECIST 1.1 by BICR.

**Measure:** Efficacy Phase: Clinical benefit rate (CBR)

**Time Frame:** Up to ~43 months

### Eligibility Module

**Eligibility Criteria:** 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

Exclusion Criteria:

* 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

**Maximum Age:** 120 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** University of California at San Francisco ( Site 1008)

**State:** California

**Zip:** 94158

**Location 2:**

**City:** New Haven

**Country:** United States

**Facility:** Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)

**State:** Connecticut

**Zip:** 06510

**Location 3:**

**City:** Chicago

**Country:** United States

**Facility:** University of Chicago ( Site 1013)

**State:** Illinois

**Zip:** 60637

**Location 4:**

**City:** Iowa City

**Country:** United States

**Facility:** University of Iowa ( Site 1012)

**State:** Iowa

**Zip:** 52242

**Location 5:**

**City:** Detroit

**Country:** United States

**Facility:** Henry Ford Health System ( Site 1014)

**State:** Michigan

**Zip:** 48202

**Location 6:**

**City:** New York

**Country:** United States

**Facility:** Laura and Isaac Perlmutter Cancer Center ( Site 1016)

**State:** New York

**Zip:** 10016

**Location 7:**

**City:** New York

**Country:** United States

**Facility:** Memorial Sloan Kettering Cancer Center ( Site 1002)

**State:** New York

**Zip:** 10065

**Location 8:**

**City:** Durham

**Country:** United States

**Facility:** Duke Cancer Institute ( Site 1015)

**State:** North Carolina

**Zip:** 27710

**Location 9:**

**City:** Pittsburgh

**Country:** United States

**Facility:** UPMC Cancer Center/Hillman Cancer Center ( Site 1017)

**State:** Pennsylvania

**Zip:** 15232

**Location 10:**

**City:** Dallas

**Country:** United States

**Facility:** UTSW Medical Center ( Site 1003)

**State:** Texas

**Zip:** 75390

**Location 11:**

**City:** Blacktown

**Country:** Australia

**Facility:** Western Sydney Local Health District ( Site 1601)

**State:** New South Wales

**Zip:** 2148

**Location 12:**

**City:** Kogarah

**Country:** Australia

**Facility:** St George Hospital ( Site 1602)

**State:** New South Wales

**Zip:** 2217

**Location 13:**

**City:** Herston

**Country:** Australia

**Facility:** Royal Brisbane and Women s Hospital ( Site 1603)

**State:** Queensland

**Zip:** 4029

**Location 14:**

**City:** Heidelberg

**Country:** Australia

**Facility:** Austin Health ( Site 1600)

**State:** Victoria

**Zip:** 3084

**Location 15:**

**City:** Toronto

**Country:** Canada

**Facility:** Princess Margaret Cancer Centre ( Site 1101)

**State:** Ontario

**Zip:** M5G 1Z5

**Location 16:**

**City:** Montreal

**Country:** Canada

**Facility:** Jewish General Hospital ( Site 1100)

**State:** Quebec

**Zip:** H3T 1E2

**Location 17:**

**City:** Temuco

**Country:** Chile

**Facility:** James Lind Centro de Investigación del Cáncer ( Site 2108)

**State:** Araucania

**Zip:** 4800827

**Location 18:**

**City:** Temuco

**Country:** Chile

**Facility:** CIDO SpA-Oncology ( Site 2106)

**State:** Araucania

**Zip:** 4810148

**Location 19:**

**City:** Santiago

**Country:** Chile

**Facility:** FALP-UIDO ( Site 2100)

**State:** Region M. De Santiago

**Zip:** 7500921

**Location 20:**

**City:** Santiago

**Country:** Chile

**Facility:** Oncovida ( Site 2107)

**State:** Region M. De Santiago

**Zip:** 7510032

**Location 21:**

**City:** Santiago

**Country:** Chile

**Facility:** Bradfordhill-Clinical Area ( Site 2101)

**State:** Region M. De Santiago

**Zip:** 8420383

**Location 22:**

**City:** Viña del Mar

**Country:** Chile

**Facility:** ONCOCENTRO APYS-ACEREY ( Site 2103)

**State:** Valparaiso

**Zip:** 2520598

**Location 23:**

**City:** Valledupar

**Country:** Colombia

**Facility:** Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905)

**State:** Cesar

**Zip:** 200001

**Location 24:**

**City:** Montería

**Country:** Colombia

**Facility:** Oncomédica S.A.S ( Site 1904)

**State:** Cordoba

**Zip:** 230002

**Location 25:**

**City:** Bogota

**Country:** Colombia

**Facility:** Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900)

**State:** Distrito Capital De Bogota

**Zip:** 111321

**Location 26:**

**City:** Cali

**Country:** Colombia

**Facility:** Fundación Valle del Lili ( Site 1901)

**State:** Valle Del Cauca

**Zip:** 760032

**Location 27:**

**City:** Vandoeuvre les Nancy

**Country:** France

**Facility:** Institut De Cancerologie De Lorraine ( Site 1204)

**State:** Ain

**Zip:** 54519

**Location 28:**

**City:** Strasbourg

**Country:** France

**Facility:** Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)

**State:** Alsace

**Zip:** 67200

**Location 29:**

**City:** Toulouse Cedex 9

**Country:** France

**Facility:** Institut Claudius Regaud ( Site 1200)

**State:** Haute-Garonne

**Zip:** 31059

**Location 30:**

**City:** Villejuif

**Country:** France

**Facility:** Gustave Roussy ( Site 1202)

**State:** Val-de-Marne

**Zip:** 94800

**Location 31:**

**City:** Budapest

**Country:** Hungary

**Facility:** Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301)

**State:** Pest

**Zip:** 1122

**Location 32:**

**City:** Haifa

**Country:** Israel

**Facility:** Rambam MC ( Site 1500)

**Zip:** 3525408

**Location 33:**

**City:** Jerusalem

**Country:** Israel

**Facility:** Hadassah Medical Center-Oncology ( Site 1504)

**Zip:** 9112001

**Location 34:**

**City:** Petah Tiqwa

**Country:** Israel

**Facility:** Rabin Medical Center ( Site 1502)

**Zip:** 4941492

**Location 35:**

**City:** Ramat Gan

**Country:** Israel

**Facility:** Sheba Medical Center - Oncology Division ( Site 1501)

**Zip:** 52621

**Location 36:**

**City:** Tel Aviv

**Country:** Israel

**Facility:** Sourasky Medical Center ( Site 1503)

**Zip:** 6423906

**Location 37:**

**City:** Songpagu

**Country:** Korea, Republic of

**Facility:** Asan Medical Center ( Site 1800)

**State:** Seoul

**Zip:** 05505

**Location 38:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Severance Hospital ( Site 1802)

**Zip:** 03722

**Location 39:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Samsung Medical Center ( Site 1801)

**Zip:** 06351

**Location 40:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402)

**State:** Noord-Holland

**Zip:** 1066CX

**Location 41:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Erasmus Medisch Centrum ( Site 2401)

**State:** Zuid-Holland

**Zip:** 3015 GD

**Location 42:**

**City:** Auckland

**Country:** New Zealand

**Facility:** Auckland City Hospital ( Site 1700)

**Zip:** 1023

**Location 43:**

**City:** Bydgoszcz

**Country:** Poland

**Facility:** Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201)

**State:** Kujawsko-pomorskie

**Zip:** 85-796

**Location 44:**

**City:** Warszawa

**Country:** Poland

**Facility:** Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200

**State:** Mazowieckie

**Zip:** 02-781

**Location 45:**

**City:** Gdańsk

**Country:** Poland

**Facility:** Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202)

**State:** Pomorskie

**Zip:** 80-952

**Location 46:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Universitari Vall d Hebron ( Site 1300)

**State:** Cataluna

**Zip:** 08035

**Location 47:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario Ramon y Cajal ( Site 1301)

**Zip:** 28034

**Location 48:**

**City:** Southampton

**Country:** United Kingdom

**Facility:** Southampton General Hospital ( Site 1403)

**State:** England

**Zip:** SO16 6YD

**Location 49:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** The Beatson West of Scotland Cancer Centre ( Site 1405)

**State:** Glasgow City

**Zip:** G12 0YN

**Location 50:**

**City:** Preston

**Country:** United Kingdom

**Facility:** Royal Preston Hospital ( Site 1406)

**State:** Lancashire

**Zip:** PR2 9HT

**Location 51:**

**City:** Leicester

**Country:** United Kingdom

**Facility:** Leicester Royal Infirmary ( Site 1408)

**State:** Leicestershire

**Zip:** LE1 5WW

**Location 52:**

**City:** London

**Country:** United Kingdom

**Facility:** Barts Health NHS Trust ( Site 1401)

**State:** London, City Of

**Zip:** EC1A 7BE

**Location 53:**

**City:** Edinburgh

**Country:** United Kingdom

**Facility:** Western General Hospital ( Site 1402)

**State:** Midlothian

**Zip:** EH4 2XU

**Location 54:**

**City:** Cardiff

**Country:** United Kingdom

**Facility:** Velindre Cancer Centre Hospital ( Site 1407)

**State:** Wales

**Zip:** CF14 2TL

**Location 55:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** The Christie NHS Foundation Trust ( Site 1400)

**Zip:** M20 4BX

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

### References Module

#### See Also Links

**Label:** Merck Oncology Clinical Trials Information

**URL:** http://merckoncologyclinicaltrials.com

**Label:** Plain Language Summary

**URL:** https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-03A&kw=3475-03A

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000007680

- Term: Kidney Neoplasms

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Carcinoma, Renal Cell

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Carcinoma, Renal Cell

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002292

- Term: Carcinoma, Renal Cell

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M348353

- Name: Belzutifan

- Relevance: HIGH

- As Found: Time before

- ID: M349416

- Name: Pembrolizumab

- Relevance: HIGH

- As Found: Blind

- ID: M353738

- Name: Lenvatinib

- Relevance: HIGH

- As Found: Fibrillation

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000582435

- Term: Pembrolizumab

- ID: C000531958

- Term: Lenvatinib

- ID: C000720612

- Term: Belzutifan

### Misc Info Module

- Version Holder: 2024-05-24
