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New immunotherapy cocktails aim to outsmart resistant ovarian cancer

NCT ID NCT04918186

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 4 times

Summary

This Phase 2 study tests several immunotherapy drug combinations in women with platinum-resistant high-grade serous ovarian cancer, a type that no longer responds to standard chemotherapy. About 60 participants will receive one of five immunotherapy regimens to see which best shrinks tumors or slows progression. The goal is to find promising combinations for larger future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Durvalumab, BA3011, BA3021, ENB003, Toripalimab
What this could lead to
If successful, this could identify promising immunotherapy combinations to better control platinum-resistant ovarian cancer and guide larger future trials.
What could go wrong
This is an early Phase 2 platform study with only 60 participants. Not all drug combinations may prove effective, and side effects from immunotherapy can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * This study will enroll women with platinum resistant high grade serous ovarian cancer. * This study is open to minorities as appropriate but is not designed to measure differences in intervention effects. * All patients must be registered for screening prior to study enrollment, however, if biomarker testing results are not required prior to enrollment to a substudy, then enrollment can proceed immediately. CCTG will advise sites when biomarker testing results are required prior to substudy enrollment. Additional Criteria To Be Met Prior To Sub-study Enrollment All patients must fulfill all of the following criteria to be eligible for enrollment to the study. Additional eligibility criteria and relevant timings that are specific to a substudy are listed in each substudy specific protocol. * Patients must have platinum resistant high grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within 6 months of last platinum containing chemotherapy. Histological confirmation of the original primary tumour is required. * All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows: * Chest x-ray ≥ 20 mm * CT scan (with slice thickness of 5 mm) ≥ 10 mm - longest diameter * Physical exam (using calipers) ≥ 10 mm * Lymph nodes by CT scan ≥ 15 mm - measured in short axis * Patients must have at least one disease site amendable to pre and on-treatment biopsies and must consent to undergo these tumour biopsies. * Prior surgery is permitted provided that a minimum of at least 28 days have elapsed between any major surgical procedure and date of enrollment, and that wound healing has occurred. * Systemic Therapy: * There is no limit to the number of prior regimens for platinum-sensitive disease. However, patients may not have received more than one cytotoxic chemotherapy regimen for platinum-resistant disease. * Patients may have received non-cytotoxic therapies (excluding agents targeted by the planned substudy). Refer to each substudy protocol for exclusions. * Prior treatment with an immune checkpoint inhibitor (ICI) is permissible providing the ICI was not discontinued for severe or recurrent severe toxicity (including myocarditis, or other myocardiotoxicity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyper thyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, nephritis, Type 1 diabetes, thrombocytopenia) * A minimum of 4 weeks must have elapsed between last dose of prior therapy and enrollment. * All reversible prior toxicity must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity) * Other Therapy: • Radiation, endocrine therapy, or other non-anti-cancer investigational agents are permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose and enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. * ECOG performance status 0 or 1 and have a life expectancy ≥ 3 months. * Patients must be ≥ 18 years of age. * All patients must have consented to: 1. Release of tumour block from their primary or metastatic tumour, if available. If archival tissue is unavailable, a tumour biopsy is required during screening. The centre/pathologist must have agreed to the submission of the specimen(s). 2. Pre and on treatment tumour biopsies: * Core needle (a minimum of 6 core samples are required) or excisional biopsies or resected tissue specimens are required. * CCTG will advise sites when biomarker testing results are required prior to enrollment * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the trial. * Patients must have adequate organ and marrow function measured within 7 days prior to enrollment including; * Absolute neutrophils ≥ 1.5 x 10\^9/L (1500/µL) * Platelets ≥ 100 x 10\^9/L (100 x 103/µL) * Hemoglobin ≥90g/L\* (10.0 g/dL) with no blood transfusions in the past 28 days. * Bilirubin ≤ 1.5 x ULN (upper limit of normal)\*\* * AST \& ALT ≤ 2.5 x ULN; if patient has liver metastases ≤ 5.0 x ULN * Serum creatinine or: Creatinine clearance ≤ 1.5 x ULN / \>50 mL/min * Albumin \>35 g/L (3.5 g/dL) * INR/PTT INR \< 1.7 or PTT \< 4 seconds above control * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. * Patient must agree to return to their primary care facility for any adverse events, response assessments and follow-up, which may occur through the course of the trial. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment. * Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation Exclusion Criteria: * Patients with a history of other malignancy may be eligible if curatively treated and/or the malignancy does not affect the determination of safety or efficacy of the investigational regimen (must be confirmed with CCTG prior to enrollment). * Patients with uncontrolled or serious illnesses, or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol or substudy. This includes but is not limited to: * history of intra-abdominal abscess within 3 months prior to starting treatment; * other active infection or chronic liver disease requiring systemic therapy; * active or known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection on antiviral treatment or with detectable viral load; * history of interstitial lung disease, non-infectious pneumonitis or severe pulmonary disease exacerbated by pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc. * clinically significant pleural, pericardial, and/or peritoneal effusion (e.g., effusion affecting normal organ function and/or requiring percutaneous drainage or diuretic control); * autoimmune disease requiring chronic steroid use; * prior history of a stroke or transient ischemic attack within the last 6 months; * history of significant cardiac disease within 6 months prior to starting treatment such as myocardial infarction, unstable angina, cardiomyopathy, congestive heart failure; * prior allogeneic stem cell transplantation or organ transplantation. * Central nervous system metastases * Symptomatic uncontrolled brain metastases requiring corticosteroid treatment. * History of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting investigational agent(s). * Pregnant or lactating (breastfeeding) women. * Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents. * Active or prior documented autoimmune or inflammatory disorders, including: inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. * Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions considered to be of low risk for recurrence are permitted to enroll. * Patients must not have been administered a live vaccine ≤ 4 weeks before enrollment. Note: Seasonal vaccines for influenza are general inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed. * QTc (using the Fridericia correction calculation) \>470 msec or \>450 msec if history of additional risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BCCA - Kelowna

    NOT_YET_RECRUITING

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BCCA - Vancouver

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    NOT_YET_RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Odette Cancer Centre

    NOT_YET_RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • The University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University Health Network

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

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