Esophageal CancerPhase 2NCT02639065
A Study of Durvalumab (MEDI4736) in Esophageal Cancer
A Phase 2 study testing Durvalumab in people with Esophageal Cancer, run by Shadia Jalal, MD at 3 sites in United States.
Trial summary
This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2016to 9 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Unversity of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
About this study
Official 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
This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as:
- Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed.
- Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.
Read the detailed description
OUTLINE: This is a multi-center trial.
INVESTIGATIONAL TREATMENT:
Subjects will receive durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
The following baseline labs must be completed within 28 days prior to registration for protocol therapy:
Hematopoietic:
- White blood cell count (WBC) > 3 K/mm^3
- Hemoglobin (Hgb) > 9 g/dL. Transfusion is allowed, if needed, since patients are post esophagectomy.
- Platelets > 100 K/mm^3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm^3
Renal:
- Calculated creatinine clearance of >/= 40 cc/min using the Cockcroft-Gault formula or by 24-hour urine collection.
Hepatic:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST, SGOT) </= 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) </= 2.5 x ULN
- Conditions
- Esophageal Cancer
- Being tested
- Durvalumab
- Keywords
- Durvalumab, MEDI4736, PD-L1 inhibitor
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment | Experimental | Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence. Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With One-Year Relapse Free Survival (RFS) With Post-Operative Durvalumab
Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs.
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started The percentage of subjects who attained relapse free survival for 1 year and 95 % confidence interval has been reported here.
Measured: From the date of surgery until disease relapse or death up to a maximum of 40 months.
Secondary outcomes (1)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
One of the secondary objective in this study is to assess toxicity and tolerability of durvalumab following trimodality therapy in patients with esophageal cancer. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Adverse Event severity grades can be described as follows :
- Grade 1 indicates a mild event
- Grade 2 indicates a moderate event
- Grade 3 indicates a severe event
- Grade 4 indicates a potentially life-threatening event
- Grade 5 indicates death
Measured: From the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start27 Apr 2016
- Primary completion9 Dec 2020
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shadia Jalal, MD
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC, AstraZeneca, Big Ten Cancer Research Consortium
- Responsible party
- Sponsor-investigator, Shadia Jalal, MD, Big Ten Cancer Research Consortium
- Investigators
- Shadia Jalal, M.D., Study chair, Big Ten Cancer Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639065
- Sponsor's protocol ID
- BTCRC-ESO14-012
- Status last verified
- Sep 2023
- First submitted
- 21 Dec 2015
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mamdani H, Schneider B, Perkins SM, Burney HN, Kasi PM, Abushahin LI, Birdas T, Kesler K, Watkins TM, Badve SS, Radovich M, Jalal SI. A Phase II Trial of Adjuvant Durvalumab Following Trimodality Therapy for Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma: A Big Ten Cancer Research Consortium Study. Front Oncol. 2021 Sep 17;11:736620. doi: 10.3389/fonc.2021.736620. eCollection 2021.
PubMed 34604072
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02639065
- Acronym / sponsor ID
- BTCRC-ESO14-012
- Conditions
- Esophageal Cancer
- Keywords
- Durvalumab, MEDI4736, PD-L1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Shadia Jalal, MDUniversity, hospital or other
- Collaborators
- MedImmune LLC, AstraZeneca, Big Ten Cancer Research Consortium
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Posted 1 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as:
- Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed.
- Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.
Detailed description
OUTLINE: This is a multi-center trial.
INVESTIGATIONAL TREATMENT:
Subjects will receive durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
The following baseline labs must be completed within 28 days prior to registration for protocol therapy:
Hematopoietic:
- White blood cell count (WBC) > 3 K/mm^3
- Hemoglobin (Hgb) > 9 g/dL. Transfusion is allowed, if needed, since patients are post esophagectomy.
- Platelets > 100 K/mm^3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm^3
Renal:
- Calculated creatinine clearance of >/= 40 cc/min using the Cockcroft-Gault formula or by 24-hour urine collection.
Hepatic:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST, SGOT) </= 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) </= 2.5 x ULN
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment | Experimental | Drug: DurvalumabDurvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI47361500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence. | Drug | Investigational Treatment |
Primary outcome
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.
Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started The percentage of subjects who attained relapse free survival for 1 year and 95 % confidence interval has been reported here.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34604072Mamdani H, Schneider B, Perkins SM, Burney HN, Kasi PM, Abushahin LI, Birdas T, Kesler K, Watkins TM, Badve SS, Radovich M, Jalal SI. A Phase II Trial of Adjuvant Durvalumab Following Trimodality Therapy for Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma: A Big Ten Cancer Research Consortium Study. Front Oncol. 2021 Sep 17;11:736620. doi: 10.3389/fonc.2021.736620. eCollection 2021.
- Big Ten Cancer Research Consortium WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shadia Jalal, M.D. study chair
Big Ten Cancer Research Consortium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab in people with Esophageal Cancer, run by Shadia Jalal, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.