Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT05651594
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clinical Stage II Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Esophageal Adenocarcinoma
  • Locally Advanced Gastroesophageal Junction Adenocarcinoma
  • Metastatic Esophageal Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Unresectable Esophageal Adenocarcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tissue collection
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scans
  • Fluorouracil — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Propranolol Hydrochloride — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Perceived Stress Scale

Study Details

This phase II trial tests what effects the addition of propranolol to pembrolizumab and standard chemotherapy (mFOLFOX) may have on response to treatment in patients with esophageal or gastroesophageal junction cancer that cannot be removed by surgery and has spread to nearby tissue or lymph nodes (unresectable locally advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). Propranolol is a drug that is classified as a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Cancer patients may be under a tremendous amount of stress with elevated levels of norepinephrine (a hormone produced by the adrenal glands in response to stress). Increased adrenergic stress may dampen the immune system, which beta-blockers, like propranolol, may be able to counteract. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in the standard chemotherapy regimen, mFOLFOX (leucovorin, fluorouracil and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding propranolol to pembrolizumab and standard mFOLFOX chemotherapy may increase the effectiveness of the pembrolizumab + mFOLFOX regimen.

Key Dates

Start date
Mar 7, 2023
Status verified
Dec 2025
Primary completion
Mar 30, 2029
Completion
Mar 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (mFOLFOX6, pembrolizumab, propranolol)
    Patients receive mFOLFOX6 (leucovorin IV, oxaliplatin IV, and fluorouracil IV), pembrolizumab IV, and propranolol PO on study. Patients also undergo tumor biopsy during screening and CT scans and collection of blood samples during screening and on study.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Within 6 months of initiating combination therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Kannan Thanikachalam
[email protected]
716-845-4005
Kannan Thanikachalam, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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