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Pembrolizumab for Esophageal and Gastric Cancers (PROCEED Trial)

Phase 2

Waitlist Available

Led By Manisha Palta, MD

Research Sponsored by Duke University

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 up to 51 weeks

Awards & highlights

PROCEED Trial Summary

This trial is testing a combination of neoadjuvant pembrolizumab (a cancer treatment) with chemoradiotherapy and adjuvant pembrolizumab (also a cancer treatment) to see if it is effective and safe in patients with locally advanced esophageal and gastric cancers.

Eligible Conditions

Esophageal and Gastric Cancers

PROCEED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 51 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 51 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 51 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Pathologic Complete Response (pCR)

Secondary outcome measures

Safety of the Combined Drug Therapy With Radiation Therapy.

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

PROCEED Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm interventional studyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,034 Total Patients Enrolled

Manisha Palta, MDPrincipal InvestigatorDuke University

7 Previous Clinical Trials

13,449 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experiments that have been conducted to demonstrate the efficacy of this treatment?

"Currently, there are an abundance of clinical trials investigating this medication, 961 to be exact. Of those investigations, 122 have advanced to the third phase. While most studies are situated in Houston, Texas; a total of 35728 locations worldwide offer patients access to these treatments."

Answered by AI

How many subjects are currently engaged in this research project?

"As of now, this particular trial is not seeking out any more participants. It was first listed on October 17th 2017 and last edited November 10th 2022. If you are looking for alternative trials, people with stomach diseases can choose from 5 active studies while 961 studies related to the same treatment still have open enrollment slots."

Answered by AI

To what conditions is this remedy usually allocated?

"Malignant neoplasms can be treated with this therapy, and it has also proven successful in addressing unresectable melanoma, microsatellite instability high situations, and chemotherapy-induced disease progression."

Answered by AI

Is recruitment for this experiment ongoing?

"According to clinicaltrials.gov, this medical study is no longer actively recruiting patients as the last update was made on 11/10/2022. However, there are 966 additional trials currently accepting enrollees at this moment in time."

Answered by AI

Has this therapeutic intervention received the sanction of the FDA?

"As this is a Phase 2 trial, which suggests there are some findings that back up its safety but not efficacy, we have rated the treatment's safety at level 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)

2017. "Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03064490.