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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602377
Recruitment Status : Not yet recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Brief Summary:
Advanced 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.

Condition or disease Intervention/treatment Phase
Small Cell Ovarian Carcinoma Drug: Pembrolizumab 25 MG/ML [Keytruda] Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Advanced Small Cell Ovarian Carcinoma of Hypercalcemic Type
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2028


Arm Intervention/treatment
Experimental: Pembrolizumab
Single arm study
Drug: Pembrolizumab 25 MG/ML [Keytruda]

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.

Other Name: MK-3475




Primary Outcome Measures :
  1. Complete response rate [ Time Frame: Around 4 to 6 months of the last patient included ]
    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.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in combinaison with chemotherapy] [ Time Frame: 30 days after the end of Cycle 6 (each cycle is 21 days) ]
    Adverse Events will be described in terms of frequency according to CTCAE v5 grade

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in monotherapy] [ Time Frame: 30 days after last treatment intake ]
    Adverse Events will be described in terms of frequency according to CTCAE v5 grade

  3. Progression Free Survival (PFS) [ Time Frame: from date of inclusion to date of event, assessed up to 5 years ]
    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).

  4. Overall Survival (OS) [ Time Frame: from date of inclusion to death, assessed up to 5 years ]
    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.

  5. Partial Response Rate (PRR) [ Time Frame: Around 4 to 6 months of the last patient included ]
    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.

  6. Duration of Response (DoR) [ Time Frame: assessed up to 42 months ]
    DOR is defined as the duration from complete response is first met until the first objective documented progression, according to RECIST v1.1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient who are at least 16 years of age on the day of signing informed consent with previously untreated, pathologically confirmed Small cell carcinoma of the ovary
  2. Stage FIGO II to IV classification
  3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  4. 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)
      • 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):
  5. 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.
  6. Covered by a medical insurance
  7. Stated willingness to comply with all study procedures and availability for the duration of the study
  8. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to treatment allocation
  9. 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).

Exclusion Criteria:

  1. SCCOHT stage I
  2. 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).
  3. Patients who has 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.

  4. Patients who has had an allogenic tissue/solid organ transplant.
  5. Patient who has received prior systemic anti-cancer therapy including investigational agents
  6. Patients who has 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.
  7. Patients who has 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.

  8. Patients who has 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.

  9. Patients who has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients (refer to the IB for a list of excipients).
  10. Patients who has 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).
  11. Patients who has 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.
  12. Patients who has a history of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease that requires steroids.
  13. Has an active infection requiring systemic therapy.
  14. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
  15. 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.
  16. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  17. 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.
  18. Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
  19. Breastfeeding women
  20. Participation in another clinical study with an investigational product 30 days prior and during the treatment course, and 30 days after end of treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602377


Contacts
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Contact: Laure JERBER +33(0)-1-84-85-20-16 pembroSCCOHT@arcagy.org

Locations
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France
ICO - Paul Papin
Angers, France, 49055
Contact: Paule AUGEREAU, MD, PhD       Paule.Augereau@ico.unicancer.fr   
Centre Hospitalier Régional Universitaire de Besançon
Besançon, France, 25030
Institut Bergonié
Bordeaux, France, 33076
Contact: Anne FLOQUET, MD, PhD       A.Floquet@bordeaux.unicancer.fr   
Centre Oscar Lambret
Lille, France, 59020
Contact: Charlotte BELLIER, MD, PhD       c-bellier@o-lambret.fr   
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Contact: Laurence VENAT-BOUVET, MD, PhD       LAURENCE.VENAT-BOUVET@chu-limoges.fr   
Centre Léon Bérard
Lyon, France, 69373
Contact: Isabelle RAY-COQUARD, MD PhD       isabelle.ray-coquard@lyon.unicancer.fr   
ICM Val d'Aurelle
Montpellier, France, 34298
Contact: Michel FABBRO, MD, PhD       Michel.Fabbro@icm.unicancer.fr   
Centre Eugène Marquis
Rennes, France, 35000
Contact: Claudia LEFEUVRE PLESSE, MD, PhD       c.lefeuvre@rennes.unicancer.fr   
Institut Claudius Regaud
Toulouse, France, 31059
Contact: Laurence GLADIEFF, MD, PhD       Michel.Fabbro@icm.unicancer.fr   
Gustave Roussy
Villejuif, France, 94805
Contact: Patricia PAUTIER, MD, PhD       Patricia.PAUTIER@gustaveroussy.fr   
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Patricia PAUTIER, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT04602377    
Other Study ID Numbers: GINECO-OV243b
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents