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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

Must not have

Uncontrolled intercurrent illness

Carcinoma in-situ and tumors determined to be T1-2N0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses.

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My cancer is early stage and has not spread to lymph nodes.

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I have had pneumonitis before.

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I haven't taken immunosuppressive drugs in the last 28 days.

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I have been diagnosed with tuberculosis in the past.

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I have had cancer within the last three years.

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I do not have connective tissue disorders that prevent radiation therapy.

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I have received an organ transplant from another person.

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My cancer has spread to other parts of my body.

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I have seizures that are not controlled by medication.

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My cancer affects the upper part of my stomach.

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I have chronic Hepatitis B or a known Hepatitis C infection.

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I have been treated with drugs targeting PD-1, PD-L1, or CTLA-4.

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I have had an autoimmune or inflammatory disorder in the last 3 years.

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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

unacceptable toxicity

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407

38%

Fatigue

21%

Diarrhea

17%

Nausea

17%

Fever

17%

Anorexia

17%

Maculopapular rash

17%

Pruritus

14%

Constipation

14%

Rash maculo-papular

10%

Anemia

10%

Abdominal pain

10%

Itching

Hypothyroidism

Non-cardiac chest pain

Weight loss

Cough

Dry Skin

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3070

durvalumab

2017

Completed Phase 3

~1210