Immunotherapy + Chemotherapy for Rectal Cancer
(PANTHER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial uses a combination of radiation therapy, medication, and chemotherapy to treat patients with advanced pelvic tumors. The goal is to shrink the tumors, kill cancer cells, and enhance the overall effectiveness of the treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications that could interact with the study drugs. Specifically, you must not have taken certain drugs like BCRP substrates, P-gp substrates, strong CYP3A4 inducers, and inhibitors within 4 weeks or 5 half-lives of the drug before starting the trial. If you're on these medications, you may need to stop them before participating.
Is the combination of immunotherapy and chemotherapy for rectal cancer generally safe in humans?
Research suggests that combining immunotherapy with radiotherapy (a type of treatment using radiation) generally does not lead to excessive harmful effects, although there can be immune-related side effects. It's important for doctors to monitor for these side effects when using these treatments together.12345
How is the treatment of Immunotherapy + Chemotherapy for Rectal Cancer unique?
This treatment is unique because it combines immunotherapy (which helps the immune system fight cancer) with radiation therapy, potentially enhancing the body's ability to attack both the primary tumor and distant cancer cells, a phenomenon known as the abscopal effect. This approach is novel as it leverages the synergy between these therapies to improve outcomes in rectal cancer, which is not commonly seen in standard treatments.678910
What data supports the effectiveness of combining immunotherapy and chemotherapy for rectal cancer?
Research suggests that combining immunotherapy with radiation therapy can improve outcomes for gastrointestinal cancers, and radiotherapy has been shown to decrease local relapse rates and improve survival in rectal cancer. Additionally, combining radiotherapy with immunotherapies has shown promising results in other cancers, indicating potential benefits for rectal cancer treatment.19101112
Who Is on the Research Team?
Encouse Golden, M.D., Ph.D.
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
Adults with rectal cancer that hasn't spread or been treated yet can join this trial. They need to be in good health, not have had prior pelvic radiation or chemotherapy for rectal cancer, and agree to use contraception. Pregnant women, those with recent severe illnesses or allergies to similar drugs, and patients on certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive short-course radiotherapy to gross pelvic disease (25Gy in 5 fractions) in combination with AB928
Chemotherapy
Consolidation chemotherapy with mFOLFOX x9 cycles in combination with AB928 and AB122
Assessment
Therapeutic responses assessed with digital rectal examination, pelvic MRI, and endoscopy
Surgery
Total mesorectal excision (TME) by transabdominal resection for pathologic evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AB122
- AB928
- FOLFOX regimen
- Radiation therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Arcus Biosciences, Inc.
Industry Sponsor