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Ovarian CancerPhase 1PEMBOVNCT03596281

Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Ovarian Cancer

A Phase 1 study testing Pembrolizumab, Bevacizumab and pegylated liposomal doxorubicin (PLD) in people with Ovarian Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

French multicenter, open-label, phase 1b, evaluating via the mTPI design the paired treatment of pembrolizumab and PLD (cohort A), pembrolizumab and bevacizumab (cohort B) and finally the combination treatment of the three drugs PLD plus bevacizumab and pembrolizumab (cohort C). 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?
Pembrolizumab, Bevacizumab and pegylated liposomal doxorubicin (PLD)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteFrance
Study dates
5 Dec 2018to 11 Apr 2023
Phase
Phase 1
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 willing and able to provide written informed consent/assent for the trial and to comply with study visits and procedures as per protocol.
  • Be over 18 years of age on day of signing informed consent.
  • Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma.
  • Have received a front line platinum-based regimen (administered via either IV or IP route) per local standard of care (SOC) or treatment guideline following the primary or interval debulking surgery with documented disease recurrence.
  • Note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment. The absence of debulking for inoperable patients is permitted.
  • Have fulfilled the following additional requirements regarding prior treatments for recurrent ovarian cancer (ROC). Have received 0 to unlimited additional prior lines for treating ROC and must have a platinum-free interval (PFI) of ≤ 6 months if the last regimen received is a platinum-based.
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  • Note: PFI is defined as the time elapsed between the last dose of platinum and the documented evidence of disease progression per RECIST 1.1.
  • Prior therapy containing bevacizumab or other vascular endothelial growth factor (VEGF) pathway-target therapy is permitted.
  • HMeasurable disease (RECIST version 1.1) by investigator assessment with at least 1 unidimensional measurable lesion
  • At least one lesion amenable to biopsy, visible by imaging or without radiological guidance (e.g. vaginal lesion
  • Have no evidence or history of gastro-intestinal events defined as grade≥2, perforation, fistula, necrosis, hemorrhage or intraabdominal abscess.
  • Have no history or previous treatment of inflammatory bowel disease.
  • Left ventricular ejection fraction (LVEF) ≥ 50% as determined by gated cardiac radionucleotide scan (MUGA) or echocardiogram. Normal blood pressure (BP) or adequately treated and controlled hypertension (either systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg). No clinically significant (i.e. active) cardiovascular disease, including: myocardial infarction or unstable angina within ≤ 6 months of inclusion; New York Heart Association (NYHA) ≥grade2 Congestive Heart Failure; poorly controlled cardiac arrhythmia despite medication; peripheral vascular disease grade
  • ≥grade3.
  • Have provided tissue from an archival tissue sample if available (i.e. initial debulking or biopsy).
  • Eastern Cooperative Oncology Group (ECOG)- performance status 0-1.
  • Life expectancy ≥ 12 weeks
  • Demonstrate adequate organ function as defined in Table 2, all screening labs should be performed within 10 days of treatment initiation.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication (Reference Section 5.9.2).
  • Subjects of childbearing potential are those who have not been surgically sterilized (hysterectomy, bilateral oophorectomy or bilateral salpingectomy) or have not been free from menses for > 1 year.
  • Patient affiliated to a social security system or beneficiary of the same

Who cannot join

  • Platinum refractory cancers, defined as lack of response to salvage treatment with a disease recurrence during the first line platinum-based chemotherapy.
  • Patients with PLD-resistant EOC, as evidenced by lack of response or progression within 6 months of the last dose of PLD.
  • Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period.
  • Has had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
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  • Major surgery within 30 days or bowel resection at cytoreductive surgery within 6 months before the initiation of study treatment.
  • Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment.
  • Any previous radiotherapy to the abdomen or pelvis.
  • Previous Cerebro-Vascular Accident, Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage.
  • History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to inclusion, and known inherited (genetic) predisposition to thrombosis (such as deficit in protein C/S) or acquired predisposition to thrombosis (such as anti-phospholipid syndromes)
  • Prior history of hypertensive crisis or hypertensive encephalopathy.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy within 2 years prior to inclusion.
  • Has known symptomatic active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
  • Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months after the last dose of trial treatment
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti- PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective ethic approval (by chair or designee) is given allowing exception to this criterion for a specific subject.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: An Open-label Phase 1 of Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Platinum Resistant Epithelial Ovarian Cancer

French multicenter, open-label, phase 1b, evaluating via the mTPI design the paired treatment of pembrolizumab and PLD (cohort A), pembrolizumab and bevacizumab (cohort B) and finally the combination treatment of the three drugs PLD plus bevacizumab and pembrolizumab (cohort C). Thanks to an expansion cohort C+ the ORR will be evaluated in a total of 19 patients at the RP2 D using an exact binomial one-step Fleming-type design.

Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B,cohort C will be opened for inclusions.

Conditions
Ovarian Cancer
Being tested
Pembrolizumab, Bevacizumab, pegylated liposomal doxorubicin (PLD)
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • PembrolizumabDrug

    200mg Q3W IV

  • BevacizumabDrug

    400 or 300 mg Q3W IV

  • pegylated liposomal doxorubicin (PLD)Drug

    15 or 20 or 30 mg/m² Q3W IV

Study groups in NCT03596281
Study groupRoleWhat they receive
Cohort AExperimentalNot described
Receives: Drug: Pembrolizumab; Drug: pegylated liposomal doxorubicin (PLD)
Cohort BExperimentalNot described
Receives: Drug: Pembrolizumab; Drug: Bevacizumab

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    For all the cohorts, the dose limiting toxicity (DLT) period to determine the Maximum dose tolerated (MTD) will be 3 weeks.

    Measured: Up to 3 weeks

Timeline

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

  1. First posted23 Jul 2018
  2. Study start5 Dec 2018
  3. Primary completion11 Mar 2021
  4. Study completion11 Apr 2023

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B, cohort C will be opened for inclusions.
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03596281
Sponsor's protocol ID
2017-004197-34
Other IDs
2016/2456, 2017
Acronym
PEMBOV
Status last verified
Oct 2024
First submitted
15 Jun 2018
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pembrolizumab, Bevacizumab and pegylated liposomal doxorubicin (PLD) in people with Ovarian Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 22 inclusion and 27 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: finished, as of the sponsor's last update on 18 Oct 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 France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose Limiting Toxicity (DLT) (time frame: Up to 3 weeks). 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 NCT03596281.

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 18 Oct 2024.

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