Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED) (PROCEED)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03064490|
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : October 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Esophageal and Gastric Cancers (EGC)||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)|
|Actual Study Start Date :||October 17, 2017|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2023|
Single arm interventional study
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
Other Name: Keytruda
- Pathologic complete response [ Time Frame: 2 years ]A two-stage design will be used to test the null hypothesis that the true pCR rate is ≤ 0.30 against the alternative hypothesis that the true pCR rate is ≥ 0.50. This design will allow the trial to stop early to accept the null hypothesis. If there are no more than 4 responders (27%) in the first 15 evaluable patients, the trial will stop to accept the null. Otherwise, an additional 15 evaluable patients will be accrued.
- Safety of the combined drug therapy with radiation therapy. [ Time Frame: 2 years ]Toxicity by type and grade will be tabulated. Toxicity rates of interest will be calculated with their 80% confidence intervals. After the first 5 subjects have been accrued, an analysis will be performed to assess acute treatment-related toxicities. If more than 1, grade 3 or greater toxicities definitely related to concurrent pembrolizumab and radiotherapy are observed, then an additional five patients will be added to this treatment arm.If no issues concerning for safety are observed within 30 days of the last dose of neoadjuvant pembrolizumab (cycle 3) for the fifth patient, then the study will continue to accrue.
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): NCT03064490
|Contact: Eileen Duffy, BNS OCN CCRP||(919) email@example.com|
|United States, North Carolina|
|Duke Cancer Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Eileen Duffy, BNS OCN 919-668-3726|
|Principal Investigator: Manisha Palta, MD|
|Principal Investigator:||Manisha Palta, MD||Duke University|