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

Last updated on October 17, 2018

FOR MORE INFORMATION
Study Location
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
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 workup should be negative for the presence of a primary gastrointestinal or
breast malignancy (

- 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-?), 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.

NCT03642132
Pfizer
Recruiting
Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

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Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)
A Study To Evaluate The Efficacy And Safety Of Avelumab In Combination With Chemotherapy Followed By Maintenance Therapy Of Avelumab In Combination With Talazoparib In Patients With Previously Untreated Advanced Ovarian Cancer
This is a Phase 3, randomized, open-label, multicenter study to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with the PARP inhibitor talazoparib in patients with previously untreated advanced ovarian cancer. Eligible patients must have previously untreated histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer and must be candidates for bevacizumab in combination with platinum based chemotherapy.

This is a Phase 3, randomized, open-label, multicenter study to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with the PARP inhibitor talazoparib in patients with previously untreated advanced ovarian cancer. Eligible patients must have previously untreated histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer and must be candidates for bevacizumab in combination with platinum based chemotherapy.

The primary purpose of the study is to demonstrate that avelumab in combination with platinum-based chemotherapy followed by avelumab plus talazoparib maintenance is superior to platinum-based chemotherapy plus bevacizumab followed by bevacizumab maintenance in prolonging PFS in patients with advanced ovarian cancer.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • 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

  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
720
Same as current
May 18, 2026
February 9, 2022   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03642132
B9991030
2017?004456?30 ( EudraCT Number )
B9991030 ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Chair: Bradley Monk, MD Department of Obstetrics and Gynecology, University of Arizona College of Medicine - Phoenix
Study Chair: Jonathan Ledermann, MD UCL Cancer Institute at University College London
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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