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Gastric AdenocarcinomaPhase 2NCT03288350

mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA)

A Phase 2 study testing mDCF + Avelumab in people with Gastric Adenocarcinoma and Esophageal Adenocarcinoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, single-arm, open-label, Simon 2-stage, phase II trial in up to 55 patients with a potentially resectable, histologically-proven, adenocarcinoma or poorly differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of the esophagus. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
mDCF + Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteCanada
Study dates
22 Feb 2018to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Signed, informed consent;
  • Age 18 years or older;
  • Histological diagnosis of adenocarcinoma or poorly differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of the esophagus;
  • The tumour must be deemed by the team to be potentially resectable. This includes imaging studies (detailed below) to clinically stage the tumor and rule out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation for gastric tumors only;
  • Stage IB (TlNl only), II, IHA, IIIB;
  • Life expectancy greater than 3 months;
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  • ECOG performance status of 0-1;
  • Neutrophils ~ 1500/μL;
  • Platelet count~ 100,000/μL;
  • Hemoglobin~ 9 g/dL;
  • Total bilirubin level :S 1.5 x the upper limit of normal (ULN) range unless consistent with Gilbert's syndrome (normal direct bilirubin);
  • AST and ALT :S 2.5 x ULN;
  • If serum creatinine above upper limit of normal (ULN), creatinine clearance ~ 60 ml/min as determined by 24-h creatinine clearance or Cockcroft-Gault formula;
  • Negative pregnancy test for women of child-bearing potential; and
  • Highly effective contraception for both male and female subjects throughout the study and for at least 60 days after last avelumab treatment administration if the risk of conception exists.

Who cannot join

  • Current or prior use of immunosuppressive medication, including corticosteroids, within 7 days prior to registration EXCEPT for the following:
  • intranasal, intra-ocular, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection);
  • Systemic corticosteroids at physiologic doses :S 10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);
  • Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. However, patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
  • Prior organ transplantation, including allogeneic stem cell transplantation;
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  • Squamous-cell carcinoma diagnosis;
  • Significant acute or chronic active infections requiring systemic therapy, including, among others:
  • Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
  • Positive test for HBV surface antigen and I or confirmatory HCV RNA (if anti-HCV antibody tested positive);
  • Vaccination with live vaccines within 4 weeks of the first dose of avelumab and while on trial;
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade 2: 3 NCI CTCAE v 4.03) or to any component in avelumab's formulation, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma);
  • Known severe hypersensitivity reaction to cisplatin, docetaxel, 5-FU or drugs formulated with polysorbate;
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction(< 6 months prior to enrollment), unstable angina, congestive heart failure (2: New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication;
  • Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade> 1 ); however, alopecia, sensory neuropathy Grade :S 2, or other Grade :S 2 not constituting a safety risk based on investigator's judgment are acceptable;
  • Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
  • Known alcohol or drug abuse;
  • Prior systemic therapy for gastric cancer;
  • Prior exposure to antibodies directed at PD-1, PD-L 1, CTLA 4 antigens;
  • Pre-existing medical conditions precluding treatment, including any contraindication for major surgery;
  • Pregnancy or lactating mothers. Women of childbearing age must use contraception during and for 3 months following treatment;
  • ECOG performance status of 2 or higher;
  • Significant hearing impairment, as judged by the need for or use of a hearing aid. If there is any uncertainty regarding the degree of hearing impairment, an audiogram will be done. If the audiogram is grossly normal or shows only minor hearing impairment (i.e. not requiring hearing aid), the patient may be enrolled;
  • Unwillingness to undergo investigations and/or treatment as outlined on the study; or
  • Participation to another trial where an investigational drug is being used.
  • History of another malignancy requiring treatment within the last 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin treated curatively and in-situ cervical cancer.

Trial locations and contacts

1 site in 1 country.

Touhid Opu, MBBS, MSc contact

514-934-1934 ext. 34573

touhid.opu@mail.mcgill.ca

Canada1 site, 1 recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Penny Chipman, 514-934-1934 ext. 64802, penny.chipman@muhc.mcgill.ca

    Thierry Alcindor, MD, MSc

    Recruiting

Other trials in Canada

About this study

Official title: Phase II Trial of Perioperative PD-L1 Inhibition With Avelumab and Docetaxel, Cisplatin and 5-Fluorouracil for Resectable Locally Advanced Esophago-Gastric Adenocarcinoma

This is a single-center, single-arm, open-label, Simon 2-stage, phase II trial in up to 55 patients with a potentially resectable, histologically-proven, adenocarcinoma or poorly differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of the esophagus.

Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5- fluorouracil. Following surgery, pathologic response will be assessed. Patients will then receive adjuvant therapy consisting of 4 cycles of mDCF + avelumab. Patients will be followed to assess two-year disease-free survival rates.

The primary objective of this study is to assess the effect on pathologic complete response rate (pCR) of adding avelumab to an mDCF regimen. The secondary objectives of this study are to determine the safety of adding avelumab to an mDCF regimen and assess its effect on two-year disease-free survival.

Being tested
mDCF + Avelumab
Keywords
Phase II Trial, Esophago-Gastric Adenocarcinoma, Avelumab
Medical subject headings
Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mDCF + AvelumabDrug

    Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5-fluorouracil (mDCF), followed by surgery and assessment of pathologic response. Then they will receive 4 cycles of adjuvant therapy of mDCF and avelumab.

Study groups in NCT03288350
Study groupRoleWhat they receive
mDCF + AvelumabExperimentalPatients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5-fluorouracil, followed by surgery and assessment of pathologic response. Then they will receive 4 cycles of adjuvant therapy of docetaxel, cisplatin, 5-fluorouracil and avelumab. Docetaxel as a one-hour 40 mg/m2 IV infusion on day 1. Cisplatin 40 mg/m2 IV infusion on day 1. 5-FU 1000 mg/m2/day over 2 days. Avelumab 10 mg/kg following the completion of the mDCF regimen.
Receives: Drug: mDCF + Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response (pCR)

    Assessment of the pathologic complete response (pCR) rate after preoperative (neoadjuvant) treatment. pCR has been shown to correlate with long-term outcomes.For the purpose of this study, pCR is considered to represent grade 0 and grade 1 responses, defined by the criteria of the College of American Pathologists.

    Measured: 30±4 weeks

Secondary outcomes (2)

  1. Two-Year Disease Free Survival (DFS)

    Analysis of two-year disease-free survival (DFS) following treatment.

    Measured: 104 weeks

  2. Safety Assessment of Adding Avelumab to mDCF

    Measurement of the incidence of grade 3 or 4 avelumab-related adverse events following treatment.

    Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2017
  2. Study start22 Feb 2018
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03288350
Sponsor's protocol ID
MS100070_0073
Status last verified
Mar 2018
First submitted
15 Sep 2017
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alcindor T, Tankel J, Fiset PO, Pal S, Opu T, Strasser M, Dehghani M, Bertos N, Zuo D, Mueller C, Cools-Lartigue J, Hickeson M, Marcus V, Camilleri-Broet S, Spatz A, Evaristo G, Farag M, Artho G, Elkrief A, Saleh R, Bailey S, Park M, Huang S, Sangwan V, Ferri L. Phase 2 trial of perioperative chemo-immunotherapy for gastro-esophageal adenocarcinoma: The role of M2 macrophage landscape in predicting response. Cell Rep Med. 2025 Apr 15;6(4):102045. doi: 10.1016/j.xcrm.2025.102045.

    PubMed 40239627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mDCF + Avelumab in people with Gastric Adenocarcinoma and Esophageal Adenocarcinoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

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 15 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Touhid Opu, MBBS, MSc (514-934-1934 ext. 34573, touhid.opu@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR) (time frame: 30±4 weeks). 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 NCT03288350, 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 22 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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