A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

NCT05479045 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00005324
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

Conditions

Ovarian Cancer Stage IV; Ovarian Cancer Stage III; Ovarian Cancer Stage 3

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival

  2 years

Secondary Outcomes (5)

• Median Overall Survival

  2 years

• Overall Response Rate

  2 years

• Duration of Response

  2 years

• Disease Control Rate

  2 years

• Incidence of Adverse Events (AE)

  2 years

Study Arms (1)

NY-ESO-1 Peptide vaccine plus Toripalimab-tpzi

EXPERIMENTAL

Biological: NY-ESO-1 Peptide vaccine; Drug: Toripalimab-tpzi

Interventions

Toripalimab-tpzi DRUG

240 milligrams (mg), intravenously, every 3 weeks starting with the second dose of NY-ESO-1 Peptide vaccine

Also known as: LOQTORZI

NY-ESO-1 Peptide vaccine plus Toripalimab-tpzi

NY-ESO-1 Peptide vaccine BIOLOGICAL

300 mcg of NY-ESO-1 peptide, 100 micrograms (mcg) granulocyte-macrophage colony-stimulating factor (GM-CSF) and 1 milliliter (mL) of Montanide ISA-51 adjuvant. The first two doses will be administered subcutaneously in a 2 week interval and thereafter, remaining three doses will be administered every 3 weeks.

NY-ESO-1 Peptide vaccine plus Toripalimab-tpzi

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able and willing to provide written and signed informed consent prior to performing any protocol-related procedures, including screening evaluations.
• Women, 18 years or older, with stage III / IV platinum-refractory Ovarian Cancer (OC) (progressed on a platinum containing regimen within 6 months of therapy and adenocarcinoma histology) that can be evaluable by RECISTv1.1 criteria who progressed on standard treatment. Participants will be recruited irrespective of if they earlier received available FDA-approved therapies (including for participants with targetable mutations, such as BRCA mutations)
• Subjects will be eligible for study entry based on the following diagnostic workup:
• History/physical examination within 28 days prior to registration.
• Imaging of target lesion(s) within 28 days prior to registration.
• Study-specific assessments:
• Recovery from effects of recent surgery, radiotherapy or chemotherapy.
• Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection).
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.
• Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C).
• Any prior radiation therapy must be completed at least 4 weeks prior to registration.
• At least 4 weeks must have elapsed since major surgery.
• Subjects must have received and have progressed, are refractory, or are intolerant to standard platinum therapy. Subjects should not have received more than 2 prior lines of systemic therapy for recurrent or metastatic disease (including both standard of care and investigational therapies).
• Subjects must have at least 1 lesion that is measurable using RECIST Version 1.1 guidelines.
• A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST Version 1.1, and has clearly progressed.

You may not qualify if:

• Subjects who have received prior therapy with regimens containing nivolumab or CTLA-4, PD-L1, PD-L2 or PD-1 antagonists or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
• History of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the study drug formulations.
• Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener's granulomatosis) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Graves disease, Hashimoto disease, autoimmune diseases that will be consider stable by hormones /steroid replacement or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
• Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of the combination treatment; in the case of monoclonal antibodies, 28 days or 5 half-lives, whichever is shorter, prior to the first dose of the combination treatment.
• Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
• Current or prior use of immunosuppressive medication within 14 days prior to the first dose of any treatment regimen. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., computerized tomography (CT) scan premedication)
• History of primary immunodeficiency, solid organ transplantation, or tuberculosis.
• Test results indicating active infection with hepatitis B or C defined by positive Hepatitis B DNA, Hepatitis C RNA or known HIV infection.
• Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of investigational products).
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Georgetown University: lead
• Coherus Oncology, Inc.: collaborator

Study Sites (2)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Samir N Khleif, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)