AzTrials
AzTrials

Ovarian Cancer Stage IVPhase 2NCT05479045

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

A Phase 2 study testing NY-ESO-1 Peptide vaccine and Toripalimab-tpzi in people with Ovarian Cancer Stage IV and Ovarian Cancer Stage III, run by Georgetown University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
NY-ESO-1 Peptide vaccine and Toripalimab-tpzi
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2026to Nov 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 26Show fewer
  • 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.
  • Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator (optional).
  • Subjects must consent to provide archived tumor specimens for correlative biomarker studies. Tumor tissue must be identified and availability confirmed prior to initiation of study therapy. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.
  • All subjects are encouraged to consent to and provide both pretreatment and on-treatment (optional) tumor biopsies.
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 2 or less.
  • In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.
  • Adequate organ function as determined by:
  • Hematological: i) Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (1,000/mm3) ii) Absolute lymphocyte count (ALC) ≥ 0.5 × 109/L (500/mm3) iii) Platelet count ≥ 100 × 109/L (100,000/mm3) without transfusion support within first 2 weeks prior to first dose iv) Hemoglobin ≥ 9.0 g/dL without transfusion support within first 2 weeks prior to first dose b) Renal: i) Calculated creatinine clearance* (CrCl) or 24-hour urine CrCl > 50 mL/minute c) Hepatic: i) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); for subjects with documented/suspected Gilbert's syndrome, bilirubin ≤ 3 × ULN ii) Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (AST and/or ALT can be up to 5 × ULN in the presence of liver metastasis, but cannot be associated with concurrent elevated bilirubin)
  • Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product. The male partner of the female subject must use male condom plus, if locally available, spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Not engaging in sexual activity for the duration of the study is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
  • Females of childbearing potential are defined as those who are not surgically sterile (i.e., have not undergone bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause).
  • A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
  • Subjects must refrain from breastfeeding while on study and for 180 days after the final dose of investigational product.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE V5.0, Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss)
  • 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.
  • Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment regimen, or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable.
  • Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast or non invasive bladder carcinoma that has/have been surgically removed.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, history of myocarditis, myocardial infarction ≤6 months, or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the subject to give written informed consent. In addition, participants with a left ventricular ejection fraction (LVEF) < 50% by echocardiogram will be excluded.

About this study

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).

Being tested
NY-ESO-1 Peptide vaccine, Toripalimab-tpzi
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NY-ESO-1 Peptide vaccineBiological

    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.

  • Toripalimab-tpziDrug

    Also called LOQTORZI

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

Study groups in NCT05479045
Study groupRoleWhat they receive
NY-ESO-1 Peptide vaccine plus Toripalimab-tpziExperimentalNot described
Receives: Biological: NY-ESO-1 Peptide vaccine; Drug: Toripalimab-tpzi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Progression Free Survival

    Measured: 2 years

Secondary outcomes (5)

  1. Median Overall Survival

    per RECIST v1.1 and mRECIST v1.1

    Measured: 2 years

  2. Overall Response Rate

    based on irRECIST

    Measured: 2 years

  3. Duration of Response

    per RECIST v1.1 and mRECIST v1.1

    Measured: 2 years

  4. Disease Control Rate

    based on irRECIST

    Measured: 2 years

  5. Incidence of Adverse Events (AE)

    Safety and tolerability will be assessed by calculating the rates and frequencies of all AEs, serious adverse events (SAE), and any toxicities according to CTCAE v5.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study startSep 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2028 (estimated)

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05479045
Sponsor's protocol ID
STUDY00005324
Status last verified
Oct 2026
First submitted
26 Jul 2022
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NY-ESO-1 Peptide vaccine and Toripalimab-tpzi in people with Ovarian Cancer Stage IV and Ovarian Cancer Stage III, run by Georgetown University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05479045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in