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Platinum-based Chemotherapy

Immunotherapy + Chemoradiation Before Surgery for Esophageal Cancer

Phase 1 & 2

Recruiting

Led By Geoffrey Ku, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥18 years of age

Patients must have surgically resectable disease treatable by esophagectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing the safety of adding a new drug, durvalumab, to standard chemotherapy for colorectal cancer.

Who is the study for?

This trial is for adults with confirmed adenocarcinoma of the esophagus or gastroesophageal junction, who have not had prior chemotherapy and whose disease is limited to those areas. Participants must be in good health with adequate organ function and no history of certain autoimmune diseases or other cancers within the last three years. Women must be non-reproductive or have a negative pregnancy test, and all participants should agree to use effective contraception.Check my eligibility

What is being tested?

The study tests the safety of adding durvalumab (an anti-PDL1 antibody) to chemoradiation therapy before surgery for esophageal cancer patients. It examines how well this combination works compared to standard treatments. The treatment includes FOLFOX/Capeox or carboplatin and paclitaxel after initial chemotherapy, followed by an esophagogastrectomy.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, skin conditions like vitiligo or alopecia, thyroid issues requiring hormone replacement, digestive disturbances, blood disorders including anemia and low white cell counts, fatigue, neuropathy (nerve pain), pneumonitis (lung inflammation), liver enzyme changes, heart rhythm abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My esophageal cancer can be removed with surgery.

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My cancer has spread to nearby lymph nodes but not to distant parts of my body.

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I am not able to become pregnant or I have a negative pregnancy test.

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I have not had chemotherapy before.

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I am fully active or can carry out light work.

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My tumor is HER2 positive.

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My cancer diagnosis of the esophagus or GEJ was confirmed at Memorial Sloan Kettering.

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My cancer is located in the esophagus or where the stomach meets the esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

pathologic complete response rate

unacceptable toxicity

Secondary outcome measures

overall survival (OS)

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407

38%

Fatigue

21%

Diarrhea

17%

Pruritus

17%

Maculopapular rash

17%

Anorexia

17%

Nausea

17%

Fever

14%

Rash maculo-papular

14%

Constipation

10%

Itching

10%

Anemia

10%

Abdominal pain

Cough

Dry Skin

Dehydration

Hypothyroidism

Non-cardiac chest pain

Weight loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Esophageal CancerExperimental Treatment5 Interventions

This is a phase Ib/II trial of durvalumab (MEDI4736), a monoclonal antibody against programmed death ligand-1 (PD-L1)), and tremelimumab, an anti-CTLA-4 antibody, in combination with chemoradiation for patients with locally advanced (TanyN+M0 or T3-4NanyM0) esophageal or gastroesophageal (GE) junction adenocarcinoma.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tremelimumab

2017

Completed Phase 2

~3380

durvalumab

2017

Completed Phase 2

~400

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,783 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,265 Previous Clinical Trials

288,605,204 Total Patients Enrolled

Geoffrey Ku, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02962063 — Phase 1 & 2

Esophageal Cancer Research Study Groups: Esophageal Cancer

Esophageal Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02962063 — Phase 1 & 2

Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02962063 — Phase 1 & 2

Frequently Asked Questions

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

What conditions is durvalumab typically administered to alleviate?

"Durvalumab is effective for palliative therapies, as well as previously untreated malignant peritoneal neoplasm and sickness."

Answered by AI

What other experiments involving durvalumab have been conducted?

"Durvalumab's initial study occured in 1997 at the City of Hope Comprehensive Cancer Center. As of now, 1667 trials have been completed and 1439 are still ongoing; a majority of these clinical studies take place in Rockville Centre, New jersey."

Answered by AI

Are there any openings left in this clinical research endeavor?

"Clinicaltrials.gov confirms that this research endeavour is actively searching for participants, with the initial post date being November 1st 2016 and edits made as recently as October 21st 2022."

Answered by AI

How many sites have been selected to oversee this research?

"Seven medical centres are participating in this trial, including Memorial Sloan Kettering Rockville Centre based in Rockville Centre, Memorial Sloan Kettering Nassau located at Uniondale and the renowned Memorial Sloan Kettering Cancer Center situated in New york. Additionally, there are 4 other sites approved for patient recruitment."

Answered by AI

What is the current enrollment rate for this clinical experiment?

"Affirmative. Clinicaltrials.gov substantiates that this research project, first published on November 1st 2016, is still looking for participants. 78 patients need to be enrolled from 7 different clinical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer

2016. "Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02962063.

All > Adenocarcinoma > Esophageal Cancer