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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AE) (Phase I)
Progression free survival (PFS) (Phase IIb)
Secondary outcome measures
Anti-tumor activity (Phase I)
Anti-tumor immune responses (Phase IIb)
CA-125 reduction (Phase IIb)
+6 moreOther outcome measures
AIM gene signatures
Immune cell phenotype
Microbiome
+4 moreTrial 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
2017
Completed Phase 3
~5860
DEC-205/NY-ESO-1 Fusion Protein CDX-1401
2014
Completed Phase 2
~140
Guadecitabine
2014
Completed Phase 3
~570
Poly ICLC
2014
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,592 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
Kunle OdunsiPrincipal InvestigatorRoswell Park Cancer Institute EDDOP
7 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Your hemoglobin level is at least 10 grams per deciliter.Your liver enzyme levels are not too high.I do not have active tuberculosis.I have not had a severe infection in the last 4 weeks.You have a low number of white blood cells.Your platelet count is at least 100,000 per microliter.You have had a bone marrow or solid organ transplant from someone else in the past.I have been informed about different treatment options for my condition.Your bilirubin levels are within the normal range, unless you have Gilbert disease.Your alkaline phosphatase levels in the blood should not be too high, unless you have liver or bone issues, in which case they can be a little higher.My kidneys are working well enough (creatinine clearance >= 30).I have a significant liver condition, such as hepatitis or cirrhosis.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from their side effects.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have had more than 2 chemotherapy treatments.I have received all standard treatments known to help my condition.I can provide tissue samples from my cancer for specific tests.I can take care of myself but might not be able to do heavy physical work.I haven't taken any immune-weakening medications in the last 2 weeks.Your immune system has enough white blood cells called neutrophils.I have not had signs of infection in the last 2 weeks.I have not taken any antibiotics by mouth or IV in the last 2 weeks.You are currently using drugs or alcohol excessively, or have mental health issues.I have ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based treatments.I can have a biopsy before and during treatment.You have a history or are at risk of having an autoimmune disease.I cannot attend follow-up assessments for my treatment.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.Your blood clotting tests should be within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (atezolizumab)
- Group 2: Cohort II (guadecitabine, atezolizumab)
- Group 3: Cohort III (guadecitabine, atezolizumab, CDX-1401 vaccine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical disorders are typically treated with Guadecitabine?
"Patients suffering from weight gain, small cell lung cancer (sclc), and malignant growths can benefit from the use of Guadecitabine."
Answered by AI
In which areas are the trials of this experiment currently taking place?
"This clinical trial has 17 locations scattered throughout the nation, with Salt Lake City, Tucson and Columbus being among them. To reduce travel demands for potential participants, it is suggested to select a clinic that's closest to you."
Answered by AI
Are there any precedent experiments concerning the efficacy of Guadecitabine?
"Guadecitabine was first trialled in 2007 at the Regional Hospital Jessa Surgical Intensive Care Unit. Since then, 720 studies have been completed and 368 are still ongoing. Notably, a vast majority of these latter trials originate from Salt Lake City, Utah."
Answered by AI
How many participants are receiving treatment in this experiment?
"At this time, the clinical trial is not enrolling any new participants. This research was first posted on September 22nd 2017 and last updated October 19th 2022. Patients with fallopian tube cancer can explore 3,675 different active trials while those looking for Guadecitabine have 368 studies to review."
Answered by AI
Is there an ongoing opportunity for participants to join this research initiative?
"At this time, no further participants are being sought for the trial initially posted on September 22nd 2017 and last edited on October 19th 2022. If desired, there are currently 3675 clinical trials involving fallopian tube cancer patients actively recruiting and 368 separate studies looking to enrol guadecitabine users."
Answered by AI
What are the main aims of this clinical investigation?
"This study, which will span a duration of up to 30 days after the last dose administered, aims to measure Progression Free Survival (PFS). Secondary objectives include assessing Objective Response Rate (complete and partial response), Overall Survival (OS) and Clinical Benefit Rate."
Answered by AI
Is this trial a pioneering effort in its field?
"Presently, there are 368 studies for Guadecitabine that span 74 nations and 1,650 cities. The initial research was funded by Baxter Healthcare Corporation in 2007 and entailed 4,640 patients across its Phase 4 approval period. Since then, 720 clinical tests have been completed."
Answered by AI
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