Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06439485
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cholangiocarcinoma
  • FGFR2 Fusion

Eligibility Criteria

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

Interventions

Study Details

To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.

Key Dates

Start date
Nov 19, 2024
Status verified
Jan 2026
Primary completion
Feb 22, 2028
Completion
Feb 22, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Participants enrolled in Part 1, the dose of pemigatinib the participant receive will depend on when the participant join this study. Up to 2 dose levels of pemigatinib will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the highest dose level of pemigatinib. A second group will receive a lower dose of pemigatinib than the group before it, if intolerable side effects are seen.
  • Experimental: Part 2
    Participants in Part 2, you will receive pemigatinib at the recommended dose that was found in Part 1.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Sunyoung Lee, MD,PHD
[email protected]
713-792-2828
Sunyoung Lee, MD,PHD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

Related Studies