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Ovarian CancerPhase 2NCT05065021

Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

A Phase 2 study testing Niraparib, Dostarlimab and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by University Health Network, Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this research study is to see how useful it is to look at biomarkers in the blood and tumor tissue of participants with ovarian, fallopian tube or primary peritoneal cancer who have previously received treatment with a drug called a PARP inhibitor, and using the results to determine the best treatment… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Niraparib, Dostarlimab and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
23 Feb 2023to 6 Jun 2025
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

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Histologically confirmed ovarian, fallopian tube or primary peritoneal cancer, high grade serous or high grade endometrioid histology subtype.
  • Patients must have relapsed disease, either platinum-sensitive, resistant or refractory, with no limit to number of lines of prior systemic therapy.
  • Radiographically documented disease progression within 28 days of registration.
  • Patient must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Progression on any prior Poly (ADP-ribose) polymerase (PARP) inhibitor therapy, with no limit to number of prior lines of PARP inhibitors.
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  • Patients must have adequate bone marrow, renal and hepatic function within 7 days of registration
  • Left ventricular ejection fraction (LVEF) > 50% by echocardiograms or multigated acquisition (MUGA) scan within 28 days of registration.
  • Patients are willing to undergo tumor biopsy pre-treatment (tissue at the time of progression on PARP inhibitor therapy).
  • Availability of archival tissue (prior to PARP inhibitor therapy) for analysis.
  • Women of child-bearing potential must agree to use a highly effective contraceptive method for study-required period. A negative high sensitive urine or serum pregnancy test within 3 days prior to the initiation of therapy will be required for women of childbearing potential.
  • Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Patient must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.

Who cannot join

  • Treatment with an investigational (other than PARP inhibitor) drug within 30 days and treatment with PARP inhibitor within 14 days prior to the first dose of study medication.
  • Major surgery within 4 weeks of registration or ongoing clinically significant post-surgical complications.
  • Patients with current or are at high-risk of developing fistula, or any other gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Patients with current or history of bowel obstruction within the last 3 months.
  • Untreated unstable brain or leptomeningeal metastases.
  • Greater than +1 proteinuria on two consecutive dipsticks within 14 days of registration.
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  • Unresolved toxicity of > grade 1 from previous anti-cancer therapy (including radiotherapy).
  • .History of poorly controlled hypertension or resting blood pressure >140/90 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy within 7 days of registration.
  • Mean QTc >470 msec in screening electrocardiograms within 7 days of registration or history of familial long QT syndrome.
  • Any evidence of severe or uncontrolled diseases such as but not limited to unstable or uncompensated respiratory, cardiac, hepatic, renal disease or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, paclitaxel, dostarlimab, or niraparib.
  • Patients who have received prior weekly paclitaxel in the recurrent ovarian cancer setting.
  • Patients who have received prior PD-1 inhibitor for ovarian cancer.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of interstitial lung disease.
  • Patients with myelodysplastic syndrome/acute myeloid leukemia
  • Previous allogenic bone marrow transplant.
  • Immuno-compromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with known active hepatitis (i.e., hepatitis B or C).
  • Patients with significant hemorrhage (>30 mL bleeding/episode in previous 3 months) or hemoptysis (>5 mL fresh blood in previous 4 weeks).
  • Patients who have had recent (within 2 weeks of registration, or until any wound has completely healed) major thoracic or abdominal surgery prior to study start, or a surgical incision that is not fully healed.
  • History of stroke or transient ischemic attack within six months.
  • Patients that are receiving other anti-cancer therapy (except patient currently progressing on treatment with PARP inhibitor), radiotherapy, biological therapy or other novel agent prior to start of study treatment.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant inappropriate for entry into the study.
  • History of other primary second malignancies (except for adequately treated cutaneous basal or squamous cell carcinoma or carcinoma in situ) within < 3 years.

Trial locations and contacts

1 site in 1 country.

Stephanie Lheureux, M.D. contact

416-946-2818

stephanie.lheureux@uhn.ca

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Stephanie Lheureux, M.D., 416-946-2818, stephanie.lheureux@uhn.ca

    Recruiting

Other trials in Canada

About this study

Official title: Re-VOLVE: A Phase II Clinical Trial in Women With Ovarian Cancer Progressing Post-PARP Inhibitor With Treatment Adapted to Real-time Assessment of Evolving Genomic Resistance

The purpose of this research study is to see how useful it is to look at biomarkers in the blood and tumor tissue of participants with ovarian, fallopian tube or primary peritoneal cancer who have previously received treatment with a drug called a PARP inhibitor, and using the results to determine the best treatment for these participants. Biomarkers are molecules such as genes (molecules that contain instructions for the development and function of cells in the body) and proteins that may be used to see how well a body responds to certain treatments.

Read the detailed description

Participants who join the study will first have samples of their blood and tumor tissue collected for biomarker testing. The testing will involve a method called "sequencing". This test will look for changes in the genes of your tumor. The results of the testing will be what is called the participant's molecular profile.

All participants will first receive bevacizumab and niraparib for 3 cycles. A cycle will be 21-days in length.

Once the participant's molecular profile has been determined, the study doctor will discuss the results with the participants and they may be referred to a genetic counsellor.

Participants will then be assigned to a study cohort (group) and receive a combination of the study drugs based on the results of their genetic testing:

  • Cohort A: Participants who do not have the required gene changes will be assigned to receive niraparib, bevacizumab, and dostarlimab
  • Cohort B: Participants who have certain gene changes will receive paclitaxel, bevacizumab, and dostarlimab.
  • Cohort C: If the participant and the study doctor think that the participant is benefitting from the combination of bevacizumab and niraparib, or the molecular profile shows that bevacizumab and niraparib is the most suitable, the participant may continue to receive this drug combination.

Participants will receive the study drug combination until disease worsening or they meet the criteria for discontinuation.

Being tested
Niraparib, Dostarlimab, Bevacizumab, Paclitaxel
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • NiraparibDrug

    Also called ZEJULA

    Niraparib works by blocking poly(ADP-ribose) polymerases (PARP) 1 and PARP 2 from working. PARP 1 and PARP 2 are proteins that are involved in cell growth, cell survival, and cell death, including cancer cells. It is believed that blocking PARP1 and PARP 2 from working will slow or stop the growth of cancer cells.

  • DostarlimabDrug

    Dostarlimab is a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is created in a laboratory that seeks out specific proteins in the body that may be involved in cancers to stop tumor growth. Dostarlimab attaches to PD-1 and inhibits the interaction of PD-L1 and PD-L2 with PD-1.

  • BevacizumabDrug

    Bevacizumab is a chemotherapy drug commonly used for the treatment of various cancers.

  • PaclitaxelDrug

    Paclitaxel is a chemotherapy drug commonly used for the treatment of various cancers.

Study groups in NCT05065021
Study groupRoleWhat they receive
Initial/Cohort CExperimentalNiraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks.
Receives: Drug: Niraparib; Drug: Bevacizumab
Cohort AExperimentalNiraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards.
Receives: Drug: Niraparib; Drug: Dostarlimab; Drug: Bevacizumab
Cohort BExperimentalPaclitaxel, by vein (intravenously), once a week. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards.
Receives: Drug: Dostarlimab; Drug: Bevacizumab; Drug: Paclitaxel

What is being measured

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

  1. Percentage of participants that achieve biomarker-guided treatment

    Measured: 3 years

  2. Response rate percentage

    Measured: 3 years

Secondary outcomes (15)

  1. Overall response rate for Cohort A

    Measured: 3 years

  2. Overall response rate for Cohort B

    Measured: 3 years

  3. Overall response rate for initial cohort/Cohort C

    Measured: 3 years

  4. Progression-free survival rate for initial cohort/Cohort C

    Measured: 3 years

  5. Progression-free survival rate for initial cohort/Cohort A

    Measured: 3 years

  6. Progression-free survival rate for initial cohort/Cohort B

    Measured: 3 years

  7. CA125 response rate for initial cohort/Cohort C

    Measured: 3 years

  8. CA125 response rate for Cohort A

    Measured: 3 years

  9. CA125 response rate for Cohort B

    Measured: 3 years

  10. Disease control rate for initial cohort/Cohort C

    Measured: 3 years

  11. Disease control rate for Cohort A

    Measured: 3 years

  12. Disease control rate for Cohort B

    Measured: 3 years

  13. Percentage of participants with adverse events in the initial cohort/Cohort C

    Measured: 3 years

  14. Percentage of participants with adverse events in Cohort A

    Measured: 3 years

  15. Percentage of participants with adverse events in Cohort B

    Measured: 3 years

Timeline

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

  1. First posted1 Oct 2021
  2. Study start23 Feb 2023
  3. Primary completion6 Jun 2025 (estimated)
  4. Study completion6 Jun 2025 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065021
Sponsor's protocol ID
Re-VOLVE
Other IDs
21-5915
Status last verified
Jan 2024
First submitted
29 Sep 2021
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib, Dostarlimab and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by University Health Network, Toronto at 1 site in Canada.

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 13 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Results are not available in the source record.

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

Contact Stephanie Lheureux, M.D. (416-946-2818, stephanie.lheureux@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants that achieve biomarker-guided treatment (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT05065021.

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 17 Jan 2024.

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