TERMINATED

Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors

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Conditions

CancerRare Diseasecancer, malignancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors.

Official Title

A Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Rare Solid Tumors

Quick Facts

Study Start:2016-12-01
Study Completion:2025-09-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT02938793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of a rare advanced solid malignancy meeting EORTC criteria.
  2. * Subjects must have failed or been ineligible to receive standard treatment options if available.
  3. * Subjects must be amenable to biopsy of a tumor site or have recent (\< 2 years) archival material available.
  4. * ECOG performance status of 0 to 2.
  5. * Life expectancy \> 3 months.
  6. * Adequate normal organ and marrow function including: hemoglobin \> 9.0 g/dl; ANC \> 1500 per mm3; platelet count \> 100,000 per mm3; bilirubin \< 1.5 x ULN; ALT/AST \< 2.5 x ULN unless liver metastases present in which case must be \< 5 x ULN; creatinine clearance \> 40 ml/min by Cockcroft-Gault or 24 hour urine collection
  1. * Previous treatment with durvalumab or tremelimumab.
  2. * Prior treatment with any checkpoint inhibitor (including anti-CTLA-4, anti-PD-1 and anti-PD-L1).
  3. * Rare malignancies under investigation in other studies including thymic carcinoma, certain sarcomas, and neuroendocrine tumors.
  4. * Untreated central nervous system metastatic disease.
  5. * Active or documented autoimmune disease within previous 2 years.
  6. * Uncontrolled psoriasis.
  7. * Prior chemotherapy within 28 days of the first dose of durvalumab or tremelimumab.
  8. * Steroid exposure within 28 days of the first dose of durvalumab or tremelimumab with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid

Contacts and Locations

Principal Investigator

William J Edenfield, MD
PRINCIPAL_INVESTIGATOR
Prisma Health-Upstate

Study Locations (Sites)

Greenville Health System Cancer Institute
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: Prisma Health-Upstate

  • William J Edenfield, MD, PRINCIPAL_INVESTIGATOR, Prisma Health-Upstate

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-01
Study Completion Date2025-09-17

Study Record Updates

Study Start Date2016-12-01
Study Completion Date2025-09-17

Terms related to this study

Keywords Provided by Researchers

  • cancer, malignancy

Additional Relevant MeSH Terms

  • Cancer
  • Rare Disease