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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06439485
Other study ID # 2024-0106
Secondary ID NCI-2024-04693
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 29, 2024
Est. completion date February 22, 2030

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Sunyoung Lee, MD,PHD
Phone (713) 792-8501
Email sslee1@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Primary Objectives: • To assess the antitumor activity of the treatment combinations based on objective response rate (ORR) Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. This assessment will be confirmed in the next scheduled scan. Secondary Objectives: 1. To determine the safety and recommended phase 2 dose (RP2D) of the triple combination of pemigatinib with bevacizumab and atezolizumab in participants with FGFR-altered metastatic CCA. 2. To evaluate the duration of response in participants with best overall response of complete response (CR) or partial response (PR). 3. To evaluate PFS defined as the time from the start of study treatment to disease progression or death, whichever occurs first. 4. To evaluate the duration of OS defined as the time from the start of study treatment to death from any cause. 5. To evaluate the clinical benefit rate defined as the proportion of participants with best overall response of CR, PR, or stable disease. 6. To evaluate safety and endpoints 2-5 with the doublet of pemigatinib with atezolizumab. Exploratory Objectives: • To examine the change of the immune microenvironment on treatment by the combination using a validated immune biomarker panel and end-of-treatment genomic markers using cfDNA to study resistance to pemigatinib and response markers from trial medications.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pemigatinib
Given by PO
Atezolizumab
Given by PO and IV
Bevacizumab
Given by PO and IV

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and adverse events (AEs) Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Through study completion; an average of 1 year.
See also
  Status Clinical Trial Phase
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Recruiting NCT06420349 - NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma Phase 1
Recruiting NCT05727176 - Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement Phase 2
Recruiting NCT05791448 - AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease Phase 1
Active, not recruiting NCT04093362 - Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Phase 3
Recruiting NCT03996408 - Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma Phase 1/Phase 2
Terminated NCT02982720 - Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron Phase 2
Terminated NCT02150967 - A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma Phase 2
Recruiting NCT03982680 - Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma Phase 2
Recruiting NCT05532059 - Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients With Advanced Cholangiocarcinoma Phase 2
Terminated NCT04088188 - Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma Phase 1
Completed NCT02989857 - Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) Phase 3
Recruiting NCT05805956 - IMM2902 in Patients With Advanced Solid Tumors Expressing HER2 Phase 1/Phase 2
Terminated NCT03773302 - Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations Phase 3
Approved for marketing NCT04507503 - Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

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