Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06439836
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Emavusertib — BIOLOGICAL
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET

Study Details

This phase I trial tests the safety, side effects, best dose, and effectiveness of emavusertib (CA-4948) in combination with pembrolizumab in treating patients with urothelial cancer that has spread from where it first started to other places in the body (metastatic) and that has a resistance to PD-1/PD-L1 immune checkpoint inhibitors. CA-4948, a kinase inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving CA-4948 in combination with pembrolizumab may be safe, tolerable and/or effective in treating patients with metastatic urothelial cancer that is resistant to PD-1/PD-L1 immune checkpoint inhibitors.

Key Dates

Start date
May 5, 2025
Status verified
Feb 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CA-4948, pembrolizumab)
    Patients receive CA-4948 orally PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, CT, MRI, or PET throughout the study. Additionally, patients may undergo a tumor biopsy on study.

Primary Outcome Measure

Dose limiting toxicities (DLTs) [ Time Frame: Up to completion of cycle 1 ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Site Public Contact
[email protected]
800-826-4673
Abhishek Tripathi (PRINCIPAL_INVESTIGATOR)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Site Public Contact
[email protected]
877-827-8839
Nataliya Mar (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Site Public Contact
[email protected]
858-822-5354
Tyler Stewart (PRINCIPAL_INVESTIGATOR)
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Nataliya Mar (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Site Public Contact
305-243-2647
Jaime R. Merchan (PRINCIPAL_INVESTIGATOR)
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Site Public Contact
404-851-7115
Jacqueline T. Brown (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Site Public Contact
888-946-7447
Jacqueline T. Brown (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Site Public Contact
404-778-1868
Jacqueline T. Brown (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Site Public Contact
[email protected]
212-824-7309
Matthew D. Galsky (PRINCIPAL_INVESTIGATOR)
NYP/Weill Cornell Medical CenterNew YorkNew York10065
Site Public Contact
212-746-1848
Rohit Jain (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390
Site Public Contact
[email protected]
214-648-7097
Waddah Arafat (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC San Diego Moores Cancer Center· La Jolla, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLEmory Saint Joseph's Hospital· Atlanta, GA

Related Studies