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Ovarian CancerPhase 2IPROCNCT04918186

Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

A Phase 2 study testing Durvalumab, BA3011 and BA3021 in people with Ovarian Cancer, run by Canadian Cancer Trials Group at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is being done to answer the following question: What are the effects of a new drug or drugs on ovarian cancer? The pre-study screening may be done to test a sample of tissue for biomarkers to determine participation in the study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Durvalumab, BA3011 and BA3021
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
6 sitesin 2 countries
Study dates
3 May 2022to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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:
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  • 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:
  • 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).
  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Janet Dancey contact

613-533-6430

jdancey@ctg.queensu.ca

Pierre-Olivier Gaudreau contact

613-533-6430

p-ogaudreau@ctg.queensu.ca

6 sites in 2 countries

Canada5 sites, 5 recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5L3

    Susan Ellard, 250 712-3900 ext. 686657

    Recruiting

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Diane Provencher, 514 890-8444

    Recruiting

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

    Helen MacKay, 416 480-5145

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Stephanie Lheureux, 416 946-4501 ext. 2415

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Anna Tinker, 604 877-6000 ext. 2707

    Recruiting

Other trials in Canada

United States1 site, 1 recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

    John Moroney, 773 834-4732

    Recruiting

Other trials in United States

About this study

Official title: An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

This study is being done to answer the following question: What are the effects of a new drug or drugs on ovarian cancer? The pre-study screening may be done to test a sample of tissue for biomarkers to determine participation in the study.

Read the detailed description

This study is being conducted to determine if this approach is better or worse than the standard of care for ovarian cancer. The standard of care is defined as care most people get for ovarian cancer.

Conditions
Ovarian Cancer
Being tested
Durvalumab, BA3011, BA3021, ENB003, Toripalimab
Medical subject headings
Ovarian Neoplasms

What participants receive

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

Study groups in NCT04918186
Study groupRoleWhat they receive
Durvalumab + BA3011 (Arm Closed)ExperimentalNot described
Receives: Drug: Durvalumab; Drug: BA3011
Durvalumab + BA3021 (Arm Closed)ExperimentalNot described
Receives: Drug: Durvalumab; Drug: BA3021
ENB-003 + ToripalimabExperimentalNot described
Receives: Drug: ENB003; Drug: Toripalimab

What is being measured

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

  1. To efficiently identify based on objective response rate (ORR), by investigator assessment using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serous ovarian cancer for later validation in randomized trials

    Measured: 36 months

Secondary outcomes (4)

  1. Evaluate ORR by investigator assessment using RECIST 1.1

    Measured: 36 months

  2. Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST)

    Measured: 36 months

  3. Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST)

    Measured: 36 months

  4. Number and severity of adverse events

    Measured: 36 months

Timeline

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

  1. First posted8 Jun 2021
  2. Study start3 May 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918186
Sponsor's protocol ID
I240
Acronym
IPROC
Status last verified
Jul 2026
First submitted
26 May 2021
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • MacKay HJ, Tinker AV, Nelson BH, Zamarin D, Odunsi AO, Lheureux S, Ellard S, Smrke A, Gaudreau PO, Faulkner T, Upadhaya S, Zhou A, Tu W, Dancey J. CRI-CCTG-0003/IND.240 an immunotherapy platform study in platinum-resistant high grade serous ovarian cancer (IPROC): Sub-studies A and B: Durvalumab (D) + mecbotamab vedotin (BA3011) or ozuriftamab vedotin (BA3021). Cancer Treat Res Commun. 2026 May 28;48:101260. doi: 10.1016/j.ctarc.2026.101260. Online ahead of print.

    PubMed 42225005

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, BA3011 and BA3021 in people with Ovarian Cancer, run by Canadian Cancer Trials Group at 6 sites in 2 countries.

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 42 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Janet Dancey (613-533-6430, jdancey@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To efficiently identify based on objective response rate (ORR), by investigator assessment using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serous ovarian cancer for later validation in randomized trials (time frame: 36 months). 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 NCT04918186, which also lists 1 linked publication.

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 5 Nov 2026.

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