Immunotherapy + Vaccine for Ovarian Cancer

Recruiting at 16 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Immunostimulants, Anticoagulants, others

Disqualifiers: Transplantation, Autoimmune disease, Severe infections, 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: 30

Duration: 24 months

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1401 vaccine may enhance the expression of the genes encoding tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor cells may help the body build an effective immune response to kill tumor cells. Giving atezolizumab, guadecitabine, and CDX-1401 vaccine may work better than CDX-1401 alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Research Team

Kunle Odunsi

Principal Investigator

Roswell Park Cancer Institute EDDOP

Eligibility Criteria

This trial is for patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who have tried standard treatments. They should be expected to live more than 6 months and understand the study's investigational nature. Participants must agree to use contraception and can undergo biopsies. Those with certain blood counts, organ function levels, and no severe infections or recent treatments are eligible.

Inclusion Criteria

Life expectancy > 6 months as assessed by study physician

Your hemoglobin level is at least 10 grams per deciliter.

Your liver enzyme levels are not too high.

Exclusion Criteria

I am mentally capable of understanding and following the study's requirements.

I have been treated with drugs targeting PD-1 or PD-L1.

I haven't taken any immune-boosting drugs in the last 6 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive atezolizumab, guadecitabine, and CDX-1401 vaccine in various combinations depending on cohort assignment

24 months

Every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Every 2 months

Treatment Details

Interventions

• Atezolizumab
• CDX-1401 Vaccine
• Guadecitabine

Trial Overview The trial tests how well atezolizumab works alongside guadecitabine and CDX-1401 vaccine in treating these cancers. It aims to find the best dose of atezolizumab combined with these agents by observing their effects on the body's immune response against tumor cells.

Participant Groups

Group I: Cohort III (guadecitabine, atezolizumab, CDX-1401 vaccine) Experimental Treatment 5 Interventions

Patients receive guadecitabine and atezolizumab as in Cohort II. Patients also receive CDX-1401 vaccine IV on day 15 and poly ICLC SC on days 15-16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Cohort II (guadecitabine, atezolizumab) Experimental Treatment 3 Interventions

Patients receive guadecitabine SC on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on days 8 and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group III: Cohort I (atezolizumab) Experimental Treatment 2 Interventions

Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+