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Monoclonal Antibodies

Atezolizumab for Peritoneal Tumors (IMagyn050 Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to approximately 59 months
Awards & highlights

IMagyn050 Trial Summary

This trial is testing a new cancer treatment against the current best treatment for ovarian, fallopian tube, or primary peritoneal cancer.

Eligible Conditions
  • Peritoneal Tumors
  • Ovarian Cancer

IMagyn050 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to approximately 59 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to approximately 59 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival - ITT Population
Overall Survival - PD-L1-Positive Subpopulation
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
+1 more
Secondary outcome measures
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population
Maximum Serum Concentration (Cmax) of Atezolizumab
+10 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

IMagyn050 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Atezolizumab With Paclitaxel, Carboplatin and BevacizumabExperimental Treatment4 Interventions
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.
Group II: Placebo With Paclitaxel, Carboplatin and BevacizumabPlacebo Group4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK
42 Previous Clinical Trials
15,440 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
15,938 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,088,922 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-controlled Randomized Phase III Trial (imagyn050/gog 3015/ENGOT-OV39)
Moore, Kathleen N., Michael Bookman, Jalid Sehouli, Austin Miller, Charles Anderson, Giovanni Scambia, Tashanna Myers, et al.. 2021. “Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-controlled Randomized Phase III Trial (imagyn050/gog 3015/ENGOT-OV39)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00306.
International Journal of Gynecologic CancerJournal
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
Moore, Kathleen N, and Sandro Pignata. 2019. “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”. International Journal of Gynecologic Cancer. BMJ. doi:10.1136/ijgc-2018-000071.
clinicaltrials.govStudy
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
2017. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03038100.
~161 spots leftby Apr 2025
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