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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and willingness to sign informed consent.

Age ≥18 years.

Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma.

Has disease that is measurable per the RECIST v1.1.

Disqualifiers

Received prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks prior to initiation of study medications.

Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib.

Had prior therapy with any VEGFR-targeting agent targeting including bevacizumab, ramucirumab, pazopanib, lenvatinib, and other anti-angiogenesis inhibitors.

Has a history and/or has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung. Exceptions include calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcifications-these are allowed.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pemigatinib

    Drug

    Given by PO

  • Atezolizumab

    Drug

    Given by PO and IV

  • Bevacizumab

    Drug

    Given by PO and IV

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Part 1Experimental treatment 3 interventions
Group B: Part 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Incyte Corporation

Collaborator

Genentech, Inc.

Collaborator