Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

NCT03642132

Last updated date
Study Location
Danbury Hospital
Danbury, Connecticut, 06810, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer including carcinosarcoma with high-grade serous component.

- Patients must be candidates for bevacizumab in combination with platinum based chemotherapy and previously untreated.

- Must have completed a primary surgical debulking procedure, or be candidates for neoadjuvant chemotherapy with planned interval debulking surgery.

1. Patients who completed primary debulking must have had incompletely resected disease that is macroscopically/grossly visible and at least with lesions >1 mm and be randomized at a maximum of 8 weeks after surgery.

2. For patients who are candidates for neoadjuvant chemotherapy, the diagnoses must have been confirmed by:

- Core tissue (not fine-needle aspiration) biopsy is required for diagnosis.

- Stage IIIC-IV documented via imaging or surgery (without attempt at cytoreduction).

- Serum CA-125/CEA ratio >25. If the serum CA-125/CEA ratio is <25, then workup should be negative for the presence of a primary gastrointestinal or breast malignancy (<6 weeks before start of neoadjuvant treatment).

- Randomization must occur within 8 weeks after diagnosis.

- Availability of an archival FFPE tumor tissue block or a minimum of 25 slides, together with an accompanying original H&E slide. If archived FFPE tissue is not available, a de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies. Tumor tissue must contain 40% or greater tumor nuclei per central laboratory assessment.

- ECOG performance status 0-1

- Age >=18 years (or >=20 years in Japan).

- Adequate bone marrow, hepatic, and renal function and blood coagulation

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline
tumors) or mucinous tumors.


- Patients for whom intraperitoneal cytotoxic chemotherapy is planned.


- Prior exposure to immunotherapy with interleukin (IL)-2, interferon alpha (IFN-α), or
an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte
associated antigen 4 (anti-CTLA4) antibody (including ipilimumab), or any other
antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint
pathways, excluding therapeutic anticancer vaccines.


- Prior treatment with a PARP inhibitor.


- Prior treatment with any anti-vascular endothelial growth factor (VEGF) drug,
including bevacizumab.


- Major surgery (other than debulking or exploratory surgery for ovarian cancer) for any
reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.


- Prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation
for localized cancer of the breast, head and neck, or skin is permitted, provided that
it was completed more than three years prior to registration, and the patient remains
free of recurrent or metastatic disease.


- Prior targeted therapy (including but not limited to vaccines, antibodies, tyrosine
kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal
primary or fallopian tube carcinoma.


- Prior organ transplantation including allogenic stem cell transplantation.


- Diagnosis of Myelodysplastic Syndrome (MDS).


- Known symptomatic brain metastases requiring steroids. Patients with previously
diagnosed brain metastases are eligible if they have completed their treatment and
have recovered from the acute effects of radiation therapy or surgery prior to study
enrollment, have discontinued corticosteroid treatment for these metastases for at
least 4 weeks and are neurologically stable.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)
Official Title  ICMJE A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)
Brief Summary JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.
Detailed Description

JAVELIN Ovarian PARP 100 (B9991030) is an open-label, international, multi-center, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The primary endpoint is progression-free survival (PFS) as determined based on blinded independent central review (BICR) assessment per RECIST v1.1.

On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study. The alliance has notified health authorities and trial investigators of the decision to discontinue the trial. The decision was based on several emerging factors since the trial's initiation, including the previously announced interim results from JAVELIN Ovarian 100 study (B9991010), which was stopped due to futility of efficacy at a planned interim analysis on 21 December 2018. The alliance determined that the degree of benefit observed with avelumab in frontline ovarian cancer in that study does not support continuation of the JAVELIN Ovarian PARP 100 trial in an unselected patient population and emphasizes the need to better understand the role of immunotherapy in ovarian cancer. Additional factors include the rapidly changing treatment landscape and the approval of a PARP inhibitor in the frontline maintenance setting. The decision to discontinue the JAVELIN Ovarian PARP 100 trial was not made for safety reasons.

Patients who remain in the study will continue receiving investigational products according to their randomized treatment assignment and will be monitored for appropriate safety assessments until treatment discontinuation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Chemotherapy + avelumab followed by avelumab + talazoparib

    Chemotherapy Period Paclitaxel Carboplatin Avelumab

    Maintenance Period Avelumab Talazoparib

  • Drug: Chemotherapy followed by talazoparib maintenance

    Chemotherapy Period Paclitaxel Carboplatin

    Maintenance Period Talazoparib

  • Drug: Chemotherapy + bevacizumab followed by bevacizumab

    Chemotherapy Period Paclitaxel Carboplatin Bevacizumab

    Maintenance Period Bevacizumab

Study Arms  ICMJE
  • Experimental: chemotherapy, avelumab and talazoparib
    Platinum-based chemotherapy + avelumab followed by avelumab + talazoparib maintenance
    Intervention: Drug: Chemotherapy + avelumab followed by avelumab + talazoparib
  • Experimental: chemotherapy, and talazoparib
    Platinum-based chemotherapy followed by talazoparib maintenance
    Intervention: Drug: Chemotherapy followed by talazoparib maintenance
  • Active Comparator: chemotherapy and bevacizumab
    Platinum-based chemotherapy + bevacizumab followed by bevacizumab maintenance
    Intervention: Drug: Chemotherapy + bevacizumab followed by bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
79
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2018)
720
Estimated Study Completion Date  ICMJE October 9, 2021
Estimated Primary Completion Date October 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer including carcinosarcoma with high-grade serous component.
  • Patients must be candidates for bevacizumab in combination with platinum based chemotherapy and previously untreated.
  • Must have completed a primary surgical debulking procedure, or be candidates for neoadjuvant chemotherapy with planned interval debulking surgery.

    1. Patients who completed primary debulking must have had incompletely resected disease that is macroscopically/grossly visible and at least with lesions >1 mm and be randomized at a maximum of 8 weeks after surgery.
    2. For patients who are candidates for neoadjuvant chemotherapy, the diagnoses must have been confirmed by:

      • Core tissue (not fine-needle aspiration) biopsy is required for diagnosis.
      • Stage IIIC-IV documented via imaging or surgery (without attempt at cytoreduction).
      • Serum CA-125/CEA ratio >25. If the serum CA-125/CEA ratio is <25, then workup should be negative for the presence of a primary gastrointestinal or breast malignancy (<6 weeks before start of neoadjuvant treatment).
      • Randomization must occur within 8 weeks after diagnosis.
  • Availability of an archival FFPE tumor tissue block or a minimum of 25 slides, together with an accompanying original H&E slide. If archived FFPE tissue is not available, a de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies. Tumor tissue must contain 40% or greater tumor nuclei per central laboratory assessment.
  • ECOG performance status 0-1
  • Age >=18 years (or >=20 years in Japan).
  • Adequate bone marrow, hepatic, and renal function and blood coagulation

Exclusion Criteria:

  • Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.
  • Patients for whom intraperitoneal cytotoxic chemotherapy is planned.
  • Prior exposure to immunotherapy with interleukin (IL)-2, interferon alpha (IFN-?), or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (anti-CTLA4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, excluding therapeutic anticancer vaccines.
  • Prior treatment with a PARP inhibitor.
  • Prior treatment with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab.
  • Major surgery (other than debulking or exploratory surgery for ovarian cancer) for any reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.
  • Prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Prior targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary or fallopian tube carcinoma.
  • Prior organ transplantation including allogenic stem cell transplantation.
  • Diagnosis of Myelodysplastic Syndrome (MDS).
  • Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Ireland,   Italy,   Japan,   Korea, Republic of,   Russian Federation,   Singapore,   Taiwan,   United States
Removed Location Countries Croatia,   Estonia,   Hungary,   Poland,   Slovakia,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT03642132
Other Study ID Numbers  ICMJE B9991030
2017-004456-30 ( EudraCT Number )
B9991030 ( Other Identifier: Alias Study Number )
JAVELIN OVARIAN PARP 100 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair:Bradley Monk, MDDepartment of Obstetrics and Gynecology, University of Arizona College of Medicine - Phoenix
Study Chair:Jonathan Ledermann, MDUCL Cancer Institute at University College London
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP