A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A

Phase 2

• Conditions: Advanced Clear Cell Renal Cell Carcinoma; kidney cancer; 10038364; 10038430

• Registration Number: NL-OMON56282
• Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

# The participant has provided documented informed consent for this study.
# Male or female from 18 years to 120 years at the time of signing the informed
consent form.
# Histologically confirmed diagnosis of locally advanced/metastatic ccRCC (with
or without sarcomatoid features).
# Not received prior systemic therapy for advanced RCC (first line). Prior
neoadjuvant/adjuvant therapy for RCC is acceptable if completed >=12 months
before randomization/allocation.
# Measurable disease by RECIST 1.1 (assessed by a Blinded Independent Central
Review).
# Karnofsky Performance Status >=70% (within 10 days before
randomization/allocation).
# Able to swallow oral medication.
# Presence of an evaluable archival or newly obtained tumor tissue sample for
central analysis.
# Adequate organ function (within 10 days before the start of study
intervention).
# If on bone resorptive therapy, this must be initiated at least 2 weeks before
randomization/allocation.
# Adequately controlled blood pressure with or without antihypertensive
medications.
# A male participant must agree to use contraception as detailed in the
protocol.
# A female participant is eligible to participate if not pregnant or
breastfeeding, agrees to follow the contraceptive guidance as detailed in the
protocol, or is not of child-bearing potential.

Exclusion Criteria

# Previously randomized/allocated to study intervention in any substudy of
protocol MK3475-U03.
# Received an investigational product or used an investigational device within
4 weeks before the first dose of study intervention.
# Prior radiotherapy within 2 weeks before the first dose of study intervention
or radiation-related toxicities requiring corticosteroids (exceptions per
protocol).
# Live or live attenuated vaccine within 30 days before the first dose of study
intervention.
# Allogeneic tissue/solid organ transplant.
# Clinically significant cardiovascular disease within 12 months before first
dose of study intervention (details per protocol).
# Prolongation of QTcF interval to >480 ms.
# LVEF below the institutional normal range as determined by MUGA or ECHO.
# Major surgery within 3 weeks before first dose of study intervention.
# Urine protein >=1 g/24 hours.
# History of interstitial lung disease, history of (noninfectious) pneumonitis
that required steroids, or current pneumonitis.
# Symptomatic pleural effusion (details per protocol).
# History of inflammatory bowel disease.
# Preexisting grade >=3 GI or non-GI fistula, or malabsorption due to prior GI
surgery or GI disease.
# Active hemoptysis within 3 weeks prior to the first dose of study
intervention.
# Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy
(or any other form of immunosuppressive therapy) within 7 days before the first
dose of study intervention.
# Known additional malignancy that is progressing or required active treatment
within the past 3 years (exceptions per protocol).
# Known active CNS metastases and/or carcinomatous meningitis (exceptions per
protocol).
# Radiographic evidence of encasement or invasion of a major blood vessel, or
of intratumoral cavitation.
# History of (severe) hypersensitivity reaction to any of the investigational
products included in this protocol.
# Active autoimmune disease that required systemic treatment in the past 2
years (details and exceptions per protocol).
# Active infection requiring systemic therapy.
# Known history of HIV and/or hepatitis B infection, or known active hepatitis
C infection.
# Pulse oximeter reading <92% at rest, or requiring intermittent or chronic
supplemental oxygen.
# Known psychiatric or substance abuse disorder that would interfere with the
participant*s ability to cooperate with the requirements of the study.
# History or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant*s participation for the full duration of the study, or is not in
the best interest of the participant to participate, in the opinion of the
treating investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified