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A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (IMagyn050)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03038100
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE January 31, 2017
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE March 8, 2017
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months) ]
  • PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death−Ligand 1 (PD-L1)−Positive Subpopulation [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months) ]
  • Overall Survival - ITT Population [ Time Frame: From randomization up to death from any cause (up to approximately 60 months) ]
  • Overall Survival - PD-L1−Positive Subpopulation [ Time Frame: From randomization up to death from any cause (up to approximately 60 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 56 months) ]
  • PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death−Ligand 1 (PD-L1)−Positive Subpopulation [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 56 months) ]
  • Overall Survival - ITT Population [ Time Frame: From randomization up to death from any cause ( up to approximately 56 months) ]
  • Overall Survival - PD-L1−Positive Subpopulation [ Time Frame: From randomization up to death from any cause ( up to approximately 56 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months) ]
  • Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group [ Time Frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months) ]
  • Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain or Bloating - Neoadjuvant Group [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 60 months) ]
    Clinically-meaningful improvement in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).
  • Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 60 months) ]
    Clinically-meaningful improvement in patient-reported function and HRQoL will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
  • Percentage of Participants who Achieve a Clinically-Meaningful Improvement, Remain Stable or Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months) ]
    Clinically-meaningful improvement in patient-reported function and HRQoL will be assessed using EORTC QLQ-C30.
  • Percentage of Participants With Adverse Events [ Time Frame: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 82 weeks) ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Pre-infusion (0 hour [hr]), 30 minutes (min) after end of infusion (EOI) on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description) ]
    Primary surgery group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/=90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Pre-infusion (0 hr), 30 min after EOI on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description) ]
    Primary surgery group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/= 90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Pre-infusion (0 hr) on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description) ]
    Primary surgery group: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/= 90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 56 months) ]
  • Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group [ Time Frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 56 months) ]
  • Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain or Bloating - Neoadjuvant Group [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 60 months) ]
    Clinically-meaningful improvement in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module (EORTC QLQ-OV28).
  • Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 60 months) ]
    Clinically-meaningful improvement in patient-reported function and HRQoL will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
  • Percentage of Participants who Achieve a Clinically-Meaningful Improvement, Remain Stable or Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months) ]
    Clinically-meaningful improvement in patient-reported function and HRQoL will be assessed using EORTC QLQ-C30.
  • Percentage of Participants With Adverse Events [ Time Frame: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 82 weeks) ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Pre-infusion (0 hour [hr]), 30 minutes (min) after end of infusion (EOI) on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description) ]
    Primary surgery group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/=90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Pre-infusion (0 hr), 30 min after EOI on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description) ]
    Primary surgery group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/= 90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: Pre-infusion (0 hr) on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description) ]
    Primary surgery group: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/= 90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title  ICMJE A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
Intervention  ICMJE
  • Drug: Paclitaxel
    Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
  • Drug: Carboplatin
    Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
  • Drug: Atezolizumab
    Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
  • Drug: Bevacizumab
    Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
  • Drug: Atezolizumab Placebo
    Placebo matching to atezolizumab on Day 1 of each 21-day cycle
Study Arms  ICMJE
  • Experimental: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Atezolizumab
    • Drug: Bevacizumab
  • Placebo Comparator: Placebo With Paclitaxel, Carboplatin and Bevacizumab
    Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Bevacizumab
    • Drug: Atezolizumab Placebo
Publications * Moore KN, Pignata S. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Int J Gynecol Cancer. 2019 Jan 10. pii: ijgc-2018-000071. doi: 10.1136/ijgc-2018-000071. [Epub ahead of print]

*   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
Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
1300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2022
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy greater than (>) 12 weeks
  • For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)

Exclusion Criteria:

  • Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
  • Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
  • Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
  • Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
  • Have synchronous primary endometrial cancer
  • Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
  • Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
  • Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery. This may include but is not limited to laparotomy.
  • Have prior allogeneic bone marrow transplantation or solid organ transplant
  • Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
  • Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
  • Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
  • Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
  • Have known sensitivity to any component of bevacizumab
  • Have known sensitivity to any component of paclitaxel
  • Current treatment with anti-viral therapy for hepatitis B virus (HBV)
  • History of leptomeningeal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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,   Austria,   Belgium,   Brazil,   China,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03038100
Other Study ID Numbers  ICMJE YO39523
2016-003472-52 ( EudraCT 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 Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE
  • GOG Foundation
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2020

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