A Study of Durvalumab (MEDI4736) in Esophageal Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT02639065
• Date of registration: 21/12/2015
• Prospective Registration: Yes
• Primary sponsor: Shadia Jalal, MD
• Public title: A Study of Durvalumab (MEDI4736) in Esophageal Cancer
• Scientific title: A Phase II Study Evaluating Safety and Efficacy of Durvalumab (MEDI4736) Following Multi-modality Therapy in Esophageal Cancer: Big Ten Cancer Research Consortium BTCRC-ESO14-012
• Date of first enrolment: April 27, 2016
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02639065
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Shadia Jalal, M.D.
• Affiliation: Big Ten Cancer Research Consortium

Key inclusion & exclusion criteria

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this
study:

- Written informed consent and HIPAA authorization for release of protected health
information obtained from the subject prior to performing any protocol-related
procedures, including screening evaluations. NOTE: HIPAA authorization may be included
in the informed consent or obtained separately.

- Age = 18 years at the time of consent.

- ECOG Performance Status of 0-1 within 28 days prior to registration for protocol
therapy.

- Females of childbearing potential and males must be willing to use two effective
methods of contraception (see the protocol) from the time consent is signed until 3
months after treatment discontinuation.

- Females of childbearing potential must have a negative serum pregnancy test within 14
days prior to registration for protocol therapy. NOTE: Female subjects are considered
of child bearing potential unless they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are =60
years old and naturally postmenopausal for at least 12 consecutive months. See the
protocol.

- Histological evidence of persistent residual esophageal adenocarcinoma including
gastroesophageal junction adenocarcinoma following definitive concurrent
chemoradiotherapy (carboplatin and paclitaxel or cisplatin and 5-FU) in the surgical
sample (esophagus or lymph node or both) obtained at the time of esophagectomy. NOTE:
Persistent residual disease is defined as follows (modified from College of American
Pathologists Guidelines):

- No residual tumor (Grade 0, complete response, 0% tumor). This group will not be
included in this study.

- Marked response (Grade 1, 0-<10% residual tumor)

- Moderate response (Grade 2, 10-50% residual tumor)

- No definite response (Grade 3, >50% residual tumor)

- Minimum of 1 month and maximum of 3 months from surgical resection with no evidence of
disease progression at the time of enrollment.

- Must have adequately recovered from surgery as judged by the treating investigator.

- Subject is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including follow
up.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

- Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or cancer-specific vaccine
therapy.

- Evidence of active autoimmune disease requiring systemic treatment within preceding 3
months or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic steroids or immunosuppressive agents. Exceptions to this rule
include vitiligo, resolved childhood asthma/atopy, requirement of intermittent
bronchodilators or local steroid injections, hypothyroidism stable on hormone
replacement, psoriasis not requiring systemic treatment (within the past 2 years),
Graves's disease and Sjogren's syndrome.

- Prior malignancy is not allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, Gleason score = 7 prostate cancers, or
other cancer for which the subject has been disease-free for at least 3 years.

- Active or prior documented inflammatory bowel disease (e.g. Crohn's disease,
ulcerative colitis).

- Presence of interstitial lung disease or history of pneumonitis requiring treatment
with corticosteroids.

- Patients with diagnosis of primary immunodeficiency.

- Patients receiving chronic systemic corticosteroid therapy or other immunosuppressive
therapy within 28 days prior to registration for protocol therapy. Exceptions include
intranasal and inhaled corticosteroids or systemic corticosteroids at physiological
doses, which are not to exceed 10 mg/day of prednisone, or an equivalent
corticosteroid.

- History of allogeneic organ or stem cell transplant.

- Receipt of live attenuated vaccine within 30 days prior to registration for protocol
therapy.

- Mean QT interval corrected for heart rate (QTc) > 470 msec calculated from 3 ECGs by
Bazett's Correction.

- Ventricular arrhythmias requiring medication(s).

- Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac
arrhythmia, active peptic ulcer disease or gastritis, or active bleeding diatheses.

- History of psychiatric illness/social situations that would limit compliance with
study requirements or compromise the ability of the subject to give written informed
consent.

- Known HIV infection or chronic hepatitis B or C.

- Known history of previous clinical diagnosis of tuberculosis.

- Clinically significant infections as judged by the treating investigator. Clinically
significant is defined as an active infection requiring IV antibiotics.

- Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother, breastfeeding should be discontinued. In
addition, breast milk cannot be stored for future use while the mother is being
treated on study.

- Treatment with any investigational agent within 28 days prior to registration for
protocol therapy.

- History of hypersensitivity to durvalumab or any excipient.

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results.

- Previous enrollment in the present study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Esophageal Cancer

Intervention(s)

Drug: Durvalumab

Primary Outcome(s)

Percentage of Participants With One-Year Relapse Free Survival (RFS) With Post-Operative Durvalumab [Time Frame: From the date of surgery until disease relapse or death up to a maximum of 40 months.]

Secondary Outcome(s)

Number of Patients With Adverse Events as a Measure of Safety and Tolerability [Time Frame: From the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months.]

Secondary ID(s)

BTCRC-ESO14-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca

Big Ten Cancer Research Consortium

MedImmune LLC

Results

• Results available: Yes
• Date Posted: 01/06/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02639065