PF-08634404 + Ipilimumab for Liver Cancer

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Disqualifiers: Moderate ascites, CNS lesions, Autoimmune diseases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-08634404 (an experimental treatment), alone or with ipilimumab (an immunotherapy drug), for hepatocellular carcinoma (HCC), a type of liver cancer. It targets individuals whose cancer has spread locally or to other parts of the body and who cannot undergo surgery or other localized treatments. Participants should have HCC that has not been treated with whole-body therapies before. The medicine will be administered through IV infusions at the trial site, where medical staff will closely monitor participants.

As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must not have received any whole-body treatment for liver cancer before, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested PF-08634404 for safety both alone and with ipilimumab. Research has shown that while PF-08634404 remains under investigation, its combination with ipilimumab was selected based on safety data, indicating it is generally well-tolerated by patients. However, like many treatments, side effects may occur, so careful monitoring is important.

Ipilimumab, the other treatment in this study, has already received FDA approval for other uses, meaning its safety profile is well-known, although it can cause immune-related side effects. The combination of these treatments has shown promising results in earlier studies for liver cancer, but participants should prepare for possible side effects and discuss any concerns with the medical team.

Overall, while encouraging data exists about the safety of these treatments, participants should expect regular check-ups to manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08634404 and ipilimumab for liver cancer because these treatments offer new mechanisms of action compared to current options like sorafenib or lenvatinib. PF-08634404 is an innovative drug that targets specific cancer pathways, which could potentially enhance the immune system's ability to fight liver cancer. Ipilimumab, an immune checkpoint inhibitor, works by blocking CTLA-4, a protein that can dampen the immune response against cancer cells. Together, these treatments might provide a more robust and targeted attack on liver cancer, potentially improving outcomes for patients who haven’t responded well to existing therapies.

What evidence suggests that this trial's treatments could be effective for liver cancer?

Research has shown that PF-08634404 could be a promising treatment for hepatocellular carcinoma (HCC), a type of liver cancer. This drug targets cancer cells and blocks specific proteins (PD-1/VEGF) that aid tumor growth. Early results indicate it can effectively slow cancer cell growth. In this trial, participants in the Phase 2 arm will receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab. Ipilimumab, another drug that helps the immune system fight cancer, may enhance the effectiveness of PF-08634404. Studies on similar drug combinations, such as nivolumab and ipilimumab, have demonstrated significant anti-tumor effects in liver cancer, with some patients living longer. Both treatments in this trial offer hope for improving patient outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced liver cancer (hepatocellular carcinoma) that can't be removed by surgery and hasn't been treated with whole-body therapy before. Participants need good liver and kidney function, no major infections or autoimmune diseases, and must not have had other cancers recently.

Inclusion Criteria

My liver is working well (Child-Pugh Class A).

I have advanced or metastatic liver cancer confirmed by biopsy or clinical criteria.

I am fully active or can do light work despite my illness.

Exclusion Criteria

Participants with history of immunodeficiency

I have moderate or severe fluid buildup in my abdomen.

Participants with active autoimmune diseases requiring systemic treatment within the past 2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive sequential dose levels of PF-08634404 and ipilimumab

Approximately 24 months

Regular visits for IV infusions and monitoring

Phase 2 Treatment

Participants are randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab

Approximately 24 months

Regular visits for IV infusions and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ipilimumab
• PF-08634404

Trial Overview

The study tests a new medicine called PF-08634404 given alone or together with ipilimumab. Both are given through IV infusions to see how well they work and how safe they are in people with advanced liver cancer.

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 2 Interventions

Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.

Group II: Phase 1b Experimental Treatment 2 Interventions

Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07227012

NCT07227012 | Symbiotic-GI-13: A Study to Learn About ...

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 ...

2.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct07227012-carcinoma-trial

Clinical Trial for Carcinoma, Hepatocellular ...

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 ...

3.

clinicaltrials.eu

clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-pf-08634404-and-ipilimumab-in-adults-with-advanced-or-spreading-liver-cancer/

A study to evaluate the safety and effectiveness of PF- ...

PF-08634404 is an experimental drug being tested to see how well it works on its own and when used together with another treatment to fight liver cancer.

4.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/36716645/pfizers-new-liver-cancer-trial-signals-a-longer-term-oncology-upside-for-pfe/

Pfizer's New Liver Cancer Trial Signals a Longer-Term ...

The trial tests PF-08634404, a biological drug given by intravenous infusion, designed to target cancer cells in hepatocellular carcinoma. It is ...

5.

s206.q4cdn.com

s206.q4cdn.com/795948973/files/doc_events/2025/Nov/10/PfizerPflash_-4404-SITC-IR-Event-2025_FINAL.pdf

Pfizer Pflash: A Spotlight on the PF'4404 (SSGJ-707 / PF ...

Epidemiology data are rounded, and sourced from US CancerMPact Patient Metrics, Oracle (2025), includes total incident and newly recurrent ...

6.

renown.org

renown.org/clinical-trials-directory/1002510825

Renown Health

The study will look at the safety and effectiveness of the investigational drug PF-08634404 when given alone or in combination with the immunotherapy medicine ...