Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer (INeOV)
|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: NCT03249142|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: ARM A Durvalumab/chemotherapy association Drug: ARM B Durvalumab/Tremelimumab/chemotherapy association||Phase 1 Phase 2|
The schedule is the following:
• In a first step a run-in phase of 6 patients will be conducted to test the safety and feasibility of the combination of durvalumab with standard carboplatin-paclitaxel chemotherapy.
Cycle 1 : chemotherapy alone (day1) Cycle 2 : chemotherapy + durvalumab (day1) Cycle 3 : chemotherapy + durvalumab (day1)
• In a second step, if first-step was found feasible, a run-in phase of 6 patients will be conducted to test the safety and feasibility of the combination of durvalumab plus tremelimumab with standard carboplatin-paclitaxel chemotherapy.
Cycle 1 : chemotherapy alone (day1) Cycle 2 : chemotherapy + durvalumab + tremelimumab (day1) Cycle 3 : chemotherapy + durvalumab (day1)
- After the run-in phase, patients will be randomized in a ratio 1:1 between those included in the durvalumab-chemotherapy expansion phase (arm A) and those included in the durvalumab + tremelimumab-chemotherapy expansion phase (arm B).
This study will also allow to explore the feasibility of a salvage therapy personalized according to the results of interval surgery and type of previous neo-adjuvant therapy.
- In those patients who achieved a complete surgical resection at interval debulking surgery, adjuvant treatment will include 3 cycles of durvalumab + chemotherapy and then a follow-up period.
In patients with residual tumor at interval debulking surgery, salvage therapy will depend on the initial treatment arm allocated.
- In arm A, the tremelimumab will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab (with one cycle of tremelimumab post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.
- In arm B, the therapy will be according to the Investigator choice and managed according to local practice.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Feasibility Randomized Study of Anti-PD-L1 Durvalumab (MEDI4736) With or Without Anti-CTLA-4 Tremelimumab in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma, Treated With a First-line Neo-adjuvant Strategy|
|Actual Study Start Date :||October 18, 2017|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2022|
|Experimental: ARM A Durvalumab/chemotherapy association||
Drug: ARM A Durvalumab/chemotherapy association
NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)
|Experimental: ARM B Durvalumab/Tremelimumab/chemotherapy association||
Drug: ARM B Durvalumab/Tremelimumab/chemotherapy association
NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV + tremelimumab 75 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)
- Toxicity after neo-adjuvant treatment [ Time Frame: At the end of cycle 3 (each cycle is 21 days) ]frequency of adverse events according to CTCAE v4.03 criteria
- Toxicity after adjuvant treatment [ Time Frame: At the end of cycle 6 (each cycle is 21 days) ]
- Toxicity after maintenance therapy [ Time Frame: Up to 18 months ]
- Safety after interval debulking surgery [ Time Frame: Up to 6 months ]adverse events according to the Clavien-Dindo classification
- Progression Free Survival (PFS) based on investigator assessment using the RECIST version 1.1 [ Time Frame: From date of randomisation until the date of progression or death, which ever occurs earlier, assessed up to 36 months ]
- Sugarbaker Peritoneal Index Score (PCI) [ Time Frame: Up to 6 months ]
- Time to start of first subsequent therapy or death [ Time Frame: Up to 36 months ]
- overall survival [ Time Frame: from date of randomisation to death, assessed up to 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249142
|Hôpital Henri Duffaut|
|Institut Ste Catherine|
|ICM Val d'Aurelle|
|Nantes, France, 44202|
|Centre Hospitalier Lyon Sud|
|Pierre-Bénite, France, 69495|
|Institut René Godinot|
|Centre Eugene Marquis|
|Centre Henri Becquerel|
|Institut de Cancérologie de Lorraine|
|Principal Investigator:||Alexandra LEARY, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|