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Monoclonal Antibodies

Immunotherapy + Vaccine for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Led By Kunle Odunsi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault

All patients should have received standard of care agents, which confer clinical benefit

Must not have

Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study

Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of atezolizumab, guadecitabine, and CDX-1401 vaccine to treat ovarian, fallopian tube, or primary peritoneal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in different organs, infusion-related reactions like fever or chills, fatigue, potential changes in blood cell counts leading to increased infection risk, and possibly other symptoms not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are working well enough (creatinine clearance >= 30).

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I have received all standard treatments known to help my condition.

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I can provide tissue samples from my cancer for specific tests.

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I can take care of myself but might not be able to do heavy physical work.

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I have ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based treatments.

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I can have a biopsy before and during treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I do not have active tuberculosis.

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I have not had a severe infection in the last 4 weeks.

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I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from their side effects.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have a significant liver condition, such as hepatitis or cirrhosis.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I have not had signs of infection in the last 2 weeks.

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I have not taken any antibiotics by mouth or IV in the last 2 weeks.

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I cannot attend follow-up assessments for my treatment.

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AE) (Phase I)

Progression free survival (PFS) (Phase IIb)

Secondary study objectives

Anti-tumor activity (Phase I)

Anti-tumor immune responses (Phase IIb)

CA-125 reduction (Phase IIb)

+6 more

Other study objectives

AIM gene signatures

Immune cell phenotype

Microbiome

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort III (guadecitabine, atezolizumab, CDX-1401 vaccine)Experimental Treatment5 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 Treatment3 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 Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Guadecitabine

2014

Completed Phase 3

~730