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Small Cell Ovarian CarcinomaPhase 2PembroSCCOHTNCT04602377

Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT

A Phase 2 study testing Pembrolizumab 25 MG/ML [Keytruda] in people with Small Cell Ovarian Carcinoma, run by ARCAGY/ GINECO GROUP at 13 sites in France.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of… Read more about this study

Who is it for?
Ages 12 years and older, women only
Conditions the study is for
Small Cell Ovarian Carcinoma
What is being tested?
Pembrolizumab 25 MG/ML [Keytruda]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
13 sitesFrance
Study dates
4 Aug 2021to Feb 2030
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 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient who are at least 12 years of age on the day of signing informed consent with previously untreated, pathologically confirmed Small cell carcinoma of the ovary.Patients could be included after one cycle of chemotherapy but have to start treatment within 4 weeks after the first cycle of chemotherapy. They will start the scheme at cycle 2.
  • Stage FIGO I to IV classification
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Have adequate organ function:
  • Adequate marrow function
  • White blood cell (WBC) >2000/mm3 (stable off any growth factor within 4 weeks of first study drug administration)
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  • Neutrophils >1500/ mm3 (stable off any growth factor within 4 weeks of first study drug administration)
  • Platelets > 100 × 103/mm3 (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
  • Haemoglobin > 9 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
  • Adequate other organ functions
  • ALT and AST < 3× institutional ULN
  • Total bilirubin < 1.5× institutional ULN (except Gilbert Syndrome: < 3.0 mg/dL)
  • Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating hormone [TSH] < 10 mIU/mL) or have controlled hypothyroidism on appropriate thyroid supplementation
  • Left ventricular ejection fraction (LVEF) > 55 % measured by ECHO (preferred) or MUGA scans
  • Serum creatinine < 2× ULN or creatinine clearance (CrCl) > 60 mL/min (measured using the Cockcroft-Gault formula below):
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial, prior to any study-specific procedure. The participant may also provide consent for (140 - age in years) × weight in kg × 0.85 Female CrCl = 72 × serum creatinine in mg/dL GINECO-OV243b - PembroSCCOHT - Protocol - Version 1.2 - 10/09/2020 Page 7 sur 83 Future Biomedical Research. However, participant may participate in the main trial without participating in Future Biomedical Research.
  • Covered by a medical insurance
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to treatment allocation
  • For females of reproductive potential: use of highly effective contraception throughout the study period up to 120 days after the last dose of pembrolizumab and 180 days following the end of chemoradiotherapy (if applicable).

Who cannot join

  • Prior therapy for the disease with chemotherapy and/or an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Patients who have received a live vaccine within 30 days prior to the first dose of study drug.
  • Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Inactivated rabies vaccines are allowed.
  • Patients who have had an allogenic tissue/solid organ transplant.
  • Patient who has received more than one cycle of platinum-based chemotherapy, or any prior systemic anti-cancer therapy including investigational agents for the SCCOHT. (Patients could be included after one cycle of platinum-based therapy).
  • Patients who have a known diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
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  • Patients who have a known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Patients who have a contraindication to any component of cisplatin, adriamycine, vepeside and cyclophosphamide.
  • Note: Investigators must use the local label for contraindications, prohibited medications, and precautions for use.
  • Patients who have severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients (refer to the IB for a list of excipients).
  • Patients who have a known severe hypersensitivity (Grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients (refer to the approved product label(s) for a list of excipients).
  • Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Patients who have a history of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease that requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
  • Has a history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
  • Breastfeeding women
  • Participation in another clinical study with an investigational product 30 days prior and during the treatment course, and 30 days after end of treatment.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Latifa BOUDALI contact

+33(0)-1-84-85-20-42

pembroSCCOHT@arcagy.org

13 sites in 1 country

France13 sites, 7 recruiting

  • ICO - Paul Papin

    Angers, 49055

    Paule AUGEREAU, MD

    Recruiting

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

    Active, not recruiting

  • Centre Hospitalier Régional Universitaire de Besançon

    Besançon, 25030

    Active, not recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Active, not recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Active, not recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Active, not recruiting

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

    Laurence VENAT-BOUVET, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Isabelle RAY-COQUARD, MD

    Recruiting

  • ICM Val d'Aurelle

    Montpellier, 34298

    Withdrawn

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033

    Lauriane EBERST, MD

    Recruiting

  • Hôpital de Hautepierre

    Strasbourg

    Lauriane EBERST

    Not yet recruiting

  • Oncopole Claudius Regaud - IUCT Oncopole

    Toulouse, 31059

    Laurence GLADIEFF, MD

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Patricia PAUTIER, MD

    Recruiting

Other trials in France

About this study

Official title: Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Small Cell Ovarian Carcinoma of Hypercalcemic Type

Small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.

Being tested
Pembrolizumab 25 MG/ML [Keytruda]

What participants receive

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

  • Pembrolizumab 25 MG/ML [Keytruda]Drug

    Also called MK-3475

    Pembrolizumab (200mg flat dose) will be administred in combinaison with PAVEP chemotherapy for the first 6 cycles (21-day cycle)

    Then, Pembrolizumab (200mg flat dose) will be administred in monotherapy until one year for patients with complete response and up to two years for patients with Stable disease or Progression response after the end of first-sequence therapy (PAVEP chemotherapy +/- High dose chemotherapy) or until disease progression.

Study groups in NCT04602377
Study groupRoleWhat they receive
PembrolizumabExperimentalSingle arm study
Receives: Drug: Pembrolizumab 25 MG/ML [Keytruda]

What is being measured

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

  1. Complete response rate

    CRR is defined as the proportion of patients who reached complete response (CR), according to RECIST v1.1 after the first sequence therapy including chemotherapy associated with immunotherapy and surgery.

    Measured: Around 4 to 6 months of the last patient included

Secondary outcomes (6)

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in combinaison with chemotherapy]

    Adverse Events will be described in terms of frequency according to CTCAE v5 grade

    Measured: 30 days after the end of Cycle 6 (each cycle is 21 days)

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in monotherapy]

    Adverse Events will be described in terms of frequency according to CTCAE v5 grade

    Measured: 30 days after last treatment intake

  3. Progression Free Survival (PFS)

    PFS is defined as the time from inclusion until the date of event defined as the first objective documented progression, according to investigator assessment of RECIST v1.1 or death (by any cause in the absence of progression).

    Measured: from date of inclusion to date of event, assessed up to 5 years

  4. Overall Survival (OS)

    OS is defined as the time from the date of inclusion until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

    Measured: from date of inclusion to death, assessed up to 5 years

  5. Partial Response Rate (PRR)

    PRR is defined as the proportion of patients who reached partial response (PR), at the end of first-sequence therapy, according to RECIST v1.1.

    Measured: Around 4 to 6 months of the last patient included

  6. Duration of Response (DoR)

    DOR is defined as the duration from complete response is first met until the first objective documented progression, according to RECIST v1.1.

    Measured: assessed up to 42 months

Timeline

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

  1. First posted26 Oct 2020
  2. Study start4 Aug 2021
  3. Primary completionJun 2026 (estimated)
  4. Study completionFeb 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602377
Sponsor's protocol ID
GINECO-OV243b
Acronym
PembroSCCOHT
Status last verified
Nov 2025
First submitted
6 Oct 2020
Last updated
28 Nov 2025
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 Pembrolizumab 25 MG/ML [Keytruda] in people with Small Cell Ovarian Carcinoma, run by ARCAGY/ GINECO GROUP at 13 sites 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 20 inclusion and 22 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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 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 Latifa BOUDALI (+33(0)-1-84-85-20-42, pembroSCCOHT@arcagy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: Around 4 to 6 months of the last patient included). 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 NCT04602377.

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 28 Nov 2025.

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