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Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma

NCT03376659•Georgetown University

View on ClinicalTrials.gov

Summary

This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically proven metastatic pancreatic or colorectal adenocarcinoma with measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1 criteria.
•2. Stable on, or responding to 1st line therapy for metastatic disease
•1. At least 8 and not more than 16 weeks after initiating 1st line therapy for metastatic disease
•2. Tumor stability/response on 1st line therapy will be determined as per RECIST 1.1
•3. Prior adjuvant chemotherapy is allowed, as long as a minimum of 3 months (for pancreatic cancer) and 6 months (for colorectal cancer) has passed between the completion of adjuvant therapy and the start of first line therapy
•4. Disease that is amenable to serial biopsies
•5. ECOG performance status 0-1
•6. Age \>= 18 years
•7. Blood pressure \<160/100 mmHg
•8. Adequate hepatic, bone marrow, and renal function:
+12 more criteria

Exclusion Criteria

•1. Any prior immunotherapy or vaccine therapy
•2. History of active or prior documented autoimmune disease within the past 2 years including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, auto-immune Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following caveats:
•* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
•* Patients with Grave's disease, vitiligo, autoimmune alopecia, or psoriasis not requiring systemic treatment (within the past 2 years) are eligible upon consultation with the Study Chairs
•* Patients with questionable diagnosis of autoimmune disease who have never been treated with immunosuppressive regimen and have no ongoing symptoms at the time of enrollment may be eligible after discussion with medical monitor and principle investigator
•3. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and TNFα antagonists) within 28 days prior to Week 1, Day 1
•* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Study Co-chairs.
•* The use of inhaled, intranasal, ophthalmic or topical corticosteroids is allowed
•* The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension is allowed.
•* Physiologic doses of systemic corticosteroids at doses which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
+33 more criteria

Locations (1)

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

August 8, 2018

Primary Completion Date

August 30, 2021

Completion Date

August 1, 2023

Last Updated

February 5, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal CancerColorectal AdenocarcinomaPancreatic AdenocarcinomaMetastatic Pancreatic Cancer

Interventions

Durvalumab

DRUG

CV301

BIOLOGICAL

Capecitabine

DRUG

Bevacizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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