Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

StatusRecruiting
PhasePhase 1/2
SponsorPfizer
Started

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Record History

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  1. Study sites: 58 to 60
  2. Trial sites expanded: 54 → 58 locations
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 7 entries
  3. Trial sites expanded: 49 → 54 locationsv8
  4. Trial sites expanded: 41 → 49 locationsv7
  5. Trial sites expanded: 35 → 41 locationsv6
  6. Trial sites expanded: 11 → 35 locationsv5
  7. Trial sites expanded: 8 → 11 locationsv4
  8. Study sites: 1 to 8
    • Study title expanded, about 1 word
    v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  10. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
438 trials monitored
See 32 trials at risk
Liver Cancer
1,602 trials monitored
See 70 trials at risk
The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced or metastatic HCC. * Is not a candidate for complete surgical or loco-regional therapies. * Have not received any whole-body treatment for HCC. Participants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
Trial Details
NCT Number NCT07227012
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Carcinoma, Hepatocellular, Hepatocellular Cancer, Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Liver Neoplasms, Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular, Liver Neoplasms
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov