Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer (INeOV)
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|ClinicalTrials.gov Identifier: NCT03249142|
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : May 12, 2020
|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will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249142
|Contact: Aurélie CHABANON, PhD.||+email@example.com|
|Hôpital Henri Duffaut||Not yet recruiting|
|Institut Ste Catherine||Recruiting|
|Centre Oscar Lambret||Withdrawn|
|ICM Val d'Aurelle||Recruiting|
|Nantes, France, 44202|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre-Bénite, France, 69495|
|Institut René Godinot||Recruiting|
|Centre Eugene Marquis||Recruiting|
|Centre Henri Becquerel||Not yet recruiting|
|Institut de Cancérologie de Lorraine||Recruiting|
|Principal Investigator:||Alexandra LEARY, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|