Immunotherapy for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new immunotherapy treatment for patients with advanced ovarian cancer and other solid tumors. It seeks to determine the best dose and understand the side effects of gene-modified T cells, which are special cells designed to fight cancer, used alone or with a drug called decitabine. The trial seeks participants whose tumors express certain proteins and who have tried at least two standard treatments without success. This study might suit those with inoperable or metastatic cancer, especially if the cancer does not respond to current treatments. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have stopped any prior anti-cancer treatments at least 4 weeks before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that decitabine, when combined with chemotherapy, is safe for treating ovarian cancer. One study found that low doses of decitabine combined with carboplatin, another cancer drug, were safe for patients with ovarian cancer.
For the NY-ESO-1 TCR/dnTGFβRII treatment, early research focuses on identifying the safest dose for patients. This treatment involves modifying T-cells (a type of immune cell) to enhance their ability to fight cancer. The primary goal is to ensure safety while assessing the effectiveness of these modified T-cells.
Both treatments are under study to evaluate their safety and patient tolerance. The aim is to determine safe doses that might help combat cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Decitabine and NY-ESO-1 TCR/ dnTGFβRII for ovarian cancer because it represents a new frontier in cancer treatment. Unlike traditional chemotherapy or surgery, this approach uses immunotherapy to enhance the body's own immune system to target and destroy cancer cells. Specifically, the NY-ESO-1 TCR/ dnTGFβRII targets a unique antigen found on cancer cells, potentially offering precision treatment with fewer side effects. Additionally, Decitabine works by reactivating silenced genes that help the immune system recognize cancer cells, potentially making the treatment more effective. This innovative combination could offer new hope for patients who have not responded to standard therapies.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that combining decitabine with chemotherapy stabilized ovarian cancer in 60% of women for several months. Other studies have found that treatments using decitabine can be effective for recurrent ovarian cancer. In this trial, some participants will receive decitabine as part of the study treatment.
For the NY-ESO-1 TCR/dnTGFβRII treatment, another option in this trial, research indicates that T cell therapy, engineered to target cancer, can produce strong responses in solid tumors. Specifically, an improved version of NY-ESO-1 TCR showed a 50-61% success rate in patients with advanced cancer. These findings suggest that both treatments could help manage ovarian cancer by stabilizing the disease and triggering a strong response.12467Who Is on the Research Team?
Daniel Olson
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced cancers, like ovarian cancer or melanoma, that express NY-ESO-1 and have undergone previous treatments. Participants must be able to stay near UChicago, have a caregiver, meet specific medical criteria including organ function and HLA-A*0201 positivity. Pregnant individuals or those with severe lung conditions, active brain metastases, recent major surgeries or uncontrolled illnesses cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lead-in Cohort
Up to 6 participants will be enrolled to determine if the study treatment is safe
Dose Level -1
If the dose tested in Lead-in cohort is not safe, the dose will be lowered and up to 6 participants will be enrolled
Expansion Cohort A (Ovarian)
Up to 6 participants with Ovarian Cancer will be enrolled after the safe dose is found
Expansion Cohort B (Other Solid Tumors)
Up to 6 participants with other solid tumor cancers will be enrolled after the safe dose is found
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Decitabine
- NY-ESO-1 TCR/ dnTGFβRII
Trial Overview
The study tests gene-modified T cells combined with other drugs (Decitabine and Cyclophosphamide Conditioning) against malignancies expressing cancer-testis antigens. It aims to determine the best dose and side effects of this immunotherapy treatment in phase I/IIA settings.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Up to 6 participants will be enrolled to this arm to determine if the study treatment is safe.
Up to 6 participants with other solid tumor cancers will be enrolled to this arm after the safe dose of NY-ESO-1 TCR/ dnTGFβRII cell is found.
Up to 6 participants with Ovarian Cancer will be enrolled to this arm after the safe dose of NY-ESO-1 TCR/ dnTGFβRII cell is found.
If the dose tested in Lead in cohort is not found to be safe, the dose of the NY-ESO-1 TCR/ dnTGFβRII cell dose will be lowered and up to 6 participants will be enrolled to this arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Citations
The safety, efficacy, and treatment outcomes of a combination ...
This trial tested the safety, efficacy, and treatment outcomes of decitabine-based chemotherapy or combined with immunotherapy in recurrent ovarian cancer ...
Research progress of decitabine in the treatment of solid ...
In a meta-analysis conducted by Miriam et al., decitabine monotherapy resulted in a reported response rate of 40% [95% CI, 32–48%] in AML, with a median overall ...
The safety, efficacy, and treatment outcomes of a ...
This trial tested the safety, efficacy, and treatment outcomes of decitabine-based chemotherapy or combined with immunotherapy in recurrent ovarian cancer ...
4.
ocrahope.org
ocrahope.org/news/new-combination-therapy-for-ovarian-cancer-shows-positive-results-in-phase-i-clinical-trials/Study: Decitabine and NY-ESO-1
Done in combination with chemotherapy, 60% of women tested showed stable disease for several months following treatment. Read the full article ...
Results of a randomized phase II study.
Conclusions: This study suggests that G can resensitize OC patients to P with efficacy endpoints favoring G+C over TC of established salvage ...
A Phase I and Pharmacodynamic Study of Decitabine ...
Based on the above results, we conclude that low dose decitabine can be safely and effectively combined with carboplatin in ovarian cancer patients and ...
7.
journals.lww.com
journals.lww.com/md-journal/fulltext/2020/06190/pilot_early_phase_ii_study_of_decitabine_and.51.aspxPilot early phase II study of decitabine and carboplatin in .. ...
There is established evidence for safety of decitabine/carboplatin sequential treatment. A phase I dose escalation study in platinum-resistant ...
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