Ovarian Cancer

Ariel 4 (Assessment of Rucaparib In Ovarian CancEr TriaL)
3rd Line:  PARPinhibitor or Chemotherapy  
Study Drug: Oral rucaparib / Chemotherapy 
Main Eligibility Criteria: 

  • Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation

Main Exclusion Criteria: 

  • Active second malignancy; 
  • Prior treatment with any PARP inhibitor, including rucaparib;  

CR1621MN (Open for enrollment group D only - kidney failure)
3rd Line:  PARPinhibitor 
Study Drug: Talazoparib (PARPi)
Main Eligibility Criteria: 

  • Patient has had no clinically significant change in renal status within 3 months prior to screening
  • Patient is not currently on hemodialysis and/or peritoneal dialysis for management of chronic kidney disease or acute failure/conditions. 

Main Exclusion Criteria:

  • Serious accompanying cardiac disorder 
  • Major surgery within 28 days prior to enrollment.

CR1606ES ESPERAS (waiting list), 2nd Line
Targeted Population: Part B: Ovarian carcinoma, Endometrial carcinoma
Study Drug:  LY2880070 with Gemcitabine (Ovarian, Endometrial)
Main Inclusion Criteria:

  • Have received 1-4 prior systemic therapies for locally advanced or metastatic disease 

For Part B

  • Participants with ovarian cancer:
    • Must be eligible to receive Gemcitabine (GEM) and not refractory to GEM/carboplatin
    • May have received GEM as previous therapy under some circumstances, but must have completed the last GEM regimen at least 12 months prior to this study
  • Participants with endometrial cancer:
    • Must have histologically confirmed endometrial cancer that is metastatic or locally advanced
    • Must have failed at least 1 prior chemotherapy 

Main Exclusion Criteria:

  • Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment 
  • Have symptomatic central nervous system (CNS) metastasis; 
  • Have had radiation therapy to >25% of bone marrow
  • Have a history of another active cancer within the past year, except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin, or another in situ carcinoma that is considered cured

CR1525MK Advance Solid Tumor:  Pembrolizumab, 2nd Line
Study drug: Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
Main Inclusion criteria:

  • Any advanced solid tumor which is Microsatellite Instability (MSI)-High (MSI-H)
  • There is no limit to the number of prior treatment regimens
  • Can supply tumor tissue for study analyses 

Main Exclusion criteria:

  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Previously participated in any other pembrolizumab (MK-3475) study, or received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1), anti-PD-L2

CA209-848  Solid Tumors of High Tumor Mutational Burden (TMB-H)  Nivolumab +/- Ipilimumab
Main Inclusion Criteria:

  • Solid malignant tumor with TMB-H 
  • Available tumor tissue and blood for TMB testing 
  • Measurable disease 

Main Exclusion Criteria:

  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody

CAPTUR (Canadian Profiling and Targeted Agent Utilization Trial)
Study Drug: targeted therapies
Main Inclusion Criteria: (screening step - non-drug specific)

  • Tumour genomic or protein expression testing 
  • Patients must have measurable disease
  • ECOG performance status 0-2.

Main Exclusion criteria:

  • Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician


OVC2 - Platinum-resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer 
Study Drug: Cediranib and Olaparib or Cediranib or Olaparib or Chemotherapy (COCOS)
Main Eligibility Criteria: 

• No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting)
• Endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; 
• Clear cell, mixed epithelial, undifferentiated carcinoma, transitional cell carcinoma histologies - germline mutation carriers BRCA1/BRCA2

Main Exclusion Criteria: 

• Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway; bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
• Prior use of PARP-inhibitors

OZM 058 - Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian Tube Cancer(NEO)2nd Line
Study Drug: Olaparib
Main Eligibility Criteria:

  • Pre-operative biopsy
  • Progression free interval of at least 6 months prior to registration
  • Minimum one line of platinum base therapy

Main Exclusion Criteria:

  • Prior use of PARP-inhibitors
  • History of allergic reactions attributed to platinum precluding further use


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