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

NCT02938793 | Terminated Phase 2 FDA Drug

• 1 other identifier: ESR-15-11633
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Rare Disease

Keywords

cancer, malignancy

Outcome Measures

Primary Outcomes (2)

• Antitumor Activity

  To evaluate the antitumor activity of durvalumab in combination with tremelimumab based on immune-related Response Evaluation Criteria

  24 months

• Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]

  To assess the safety and tolerability of durvalumab in combination with tremelimumab

  24 months

Secondary Outcomes (1)

• Expression of programmed cell death protein 1 (PD-1)

  24 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300mg intravenously as a single dose on cycle 1 day 1 only.

Drug: Durvalumab; Drug: Tremelimumab

Interventions

Durvalumab DRUG

intravenous administration

Also known as: MEDI4736

Single Arm

Tremelimumab DRUG

intravenous administration

Also known as: CP-675,206

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a rare advanced solid malignancy meeting EORTC criteria.
• Subjects must have failed or been ineligible to receive standard treatment options if available.
• Subjects must be amenable to biopsy of a tumor site or have recent (\< 2 years) archival material available.
• ECOG performance status of 0 to 2.
• Life expectancy \> 3 months.
• 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

You may not qualify if:

• Previous treatment with durvalumab or tremelimumab.
• Prior treatment with any checkpoint inhibitor (including anti-CTLA-4, anti-PD-1 and anti-PD-L1).
• Rare malignancies under investigation in other studies including thymic carcinoma, certain sarcomas, and neuroendocrine tumors.
• Untreated central nervous system metastatic disease.
• Active or documented autoimmune disease within previous 2 years.
• Uncontrolled psoriasis.
• Prior chemotherapy within 28 days of the first dose of durvalumab or tremelimumab.
• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• AstraZeneca: collaborator
• MedImmune LLC: collaborator

Study Sites (1)

Greenville Health System Cancer Institute

Greenville, South Carolina, 29605, United States

Location

Related Publications (1)

• Edenfield WJ, Chung K, O'Rourke M, Cull E, Martin J, Bowers H, Smith W, Gluck WL. A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers. Oncologist. 2021 Sep;26(9):e1499-e1507. doi: 10.1002/onco.13798. Epub 2021 May 8.

  PMID: 33893692 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Rare Diseases

Interventions

durvalumab; tremelimumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William J Edenfield, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 19, 2016
• Study Start: December 1, 2016
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)