Immunotherapy + Vaccine for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of treatments, including an immunotherapy drug (Atezolizumab, also known as Tecentriq), a vaccine (CDX-1401 Vaccine), and another drug (Guadecitabine), to determine their effectiveness in fighting ovarian, fallopian tube, or primary peritoneal cancer that has returned. The goal is to enhance the immune system's ability to target and destroy cancer cells. Participants may be suitable if their cancer has returned after treatment, particularly if it has resisted standard chemotherapy. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and to measure its effectiveness in an initial, smaller group.
Do I need to stop my current medications to join the trial?
The trial requires that you stop certain medications before joining. You must discontinue chemotherapy, radiotherapy, and some immunosuppressive or immunostimulatory medications at least 2-6 weeks before starting the trial. However, some medications like low-dose corticosteroids and bisphosphonates for specific conditions are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that atezolizumab is generally well-tolerated by patients with ovarian and uterine cancer. Studies have found it safe, even when combined with other treatments like Avastin and carboplatin. For guadecitabine, safety data from several trials indicate a consistent safety record across different conditions. One study found guadecitabine to be safe and more effective compared to other treatments.
Regarding the CDX-1401 vaccine, research indicates it is safe when used with immune boosters. Patients in studies have tolerated it well, and the vaccine has triggered immune responses that may help fight cancer.
These treatments have demonstrated promising safety results, but the combination in this trial is still under study to confirm these findings.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for ovarian cancer because they combine innovative immunotherapy approaches with a novel vaccine strategy. Atezolizumab, an immune checkpoint inhibitor, enhances the body's immune response against cancer cells, which is different from traditional chemotherapy options. Guadecitabine, a DNA hypomethylating agent, potentially reactivates silenced genes that suppress tumors, offering a fresh mechanism of action. The addition of the CDX-1401 vaccine in one of the combinations aims to further stimulate the immune system by targeting specific cancer antigens. This multifaceted approach has the potential to provide improved outcomes by leveraging the body's own defenses against the cancer.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown mixed results for the treatments studied in this trial. In Cohort I, participants will receive Atezolizumab, a drug that helps the immune system fight cancer, but past studies have not shown significant benefits in improving survival or slowing ovarian cancer. In Cohort II, participants will receive a combination of Guadecitabine, a drug that can alter DNA, which had a modest success rate of about 15% in one study, and Atezolizumab. Cohort III will include Guadecitabine and Atezolizumab as in Cohort II, with the addition of the CDX-1401 vaccine, designed to help the immune system recognize and attack cancer cells. Early studies suggest the vaccine can strengthen the immune response. While each treatment has shown some potential individually, combining them in this trial aims to enhance their effectiveness against ovarian cancer.16789
Who Is on the Research Team?
Kunle Odunsi
Principal Investigator
Roswell Park Cancer Institute EDDOP
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive atezolizumab, guadecitabine, and CDX-1401 vaccine in various combinations depending on cohort assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Overall survival and patient-reported outcome results from the ...
Conclusions: Incorporation of atezolizumab into standard therapy for newly diagnosed ovarian cancer does not significantly improve efficacy or impose additional ...
2.
onclive.com
onclive.com/view/atezolizumab-plus-chemotherapy-fails-to-provide-clinical-benefit-in-rocAtezolizumab Plus Chemotherapy Fails to Provide Clinical ...
Patients with recurrent ovarian cancer did not experience a statistically significant improvement in clinical outcomes such as progression-free survival and ...
Impact of adding the immune checkpoint inhibitor ...
Adding the anti-PD-L1 antibody atezolizumab to frontline chemotherapy-bevacizumab regimen did not improve progression-free survival (PFS) in ovarian cancer ...
Roche provides update on Phase III study of Tecentriq in ...
Data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis.
NCT05001347 | A Clinical Study of TJ004309 With ...
Histologically confirmed ovarian cancer of all high-grade epithelial types who are IO treatment naïve and have progressed after 3 months on or after platinum- ...
Safety, clinical activity and biomarker assessments of ...
Conclusions: Atezolizumab monotherapy was well tolerated in patients with epithelial ovarian or uterine cancer and may have clinical activity ...
Genentech: Press Releases | Sunday, Jul 12, 2020
Topline safety data indicate that safety for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known ...
8.
sonnetbio.com
sonnetbio.com/news-media/press-releases/detail/124/sonnets-son-1010-demonstrates-a-strong-safety-profile-inSonnet's SON-1010 Demonstrates a Strong Safety Profile ...
The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg in combination with atezolizumab in patients with platinum-resistant ovarian cancer (PROC).
SON-1010 Plus Atezolizumab Is Safe, Displays ... - OncLive
SON-1010 plus atezolizumab was safe and showed clinical activity in platinum-resistant ovarian cancer and other advanced solid tumors.
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