Durvalumab and Tremelimumab in Patients With Advanced Rare Tumours

NCT02879162 | Completed Phase 2 Results DMC

• 1 other identifier: I228
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 13

Brief Summary

The standard or usual treatment for this disease may be chemotherapy or other types of treatment to slow the spread of the disease and relieve some symptoms of this cancer.

Conditions

Advanced Rare Tumours

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate Measured by RECIST Version 1.1

  Objective response rate is defined as the proportion of response evaluable patients who had complete response (CR) or partial response (PR) as their best response as assessed by RECIST version 1.1 criteria (i.e. a 30% decrease in the sum of the longest diameters of the target lesions maintained for at least 4 weeks (CR), or complete disappearance of disease and cancer related symptoms, also maintained for at least 4 weeks (CR)).

  48 months

Secondary Outcomes (2)

• Time to Progression Based on Kaplan-Meier Method

  48 months

• Progression Free Survival Based on Kaplan-Meier Method

  48 months

Study Arms (1)

Durvalumab + Tremelimumab

EXPERIMENTAL

Durvalumab 1500 mg IV 60 min Day 1 every 4 weeks Tremelimumab 75 mg IV 60 min Day 1, cycles 1-4

Drug: Durvalumab; Drug: Tremelimumab

Interventions

Durvalumab DRUG

Durvalumab + Tremelimumab

Tremelimumab DRUG

Durvalumab + Tremelimumab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically and/or cytologically confirmed cancer that is advanced / metastatic / recurrent or unresectable and for which no curative therapy exists as follows:
• Salivary carcinoma (excluding adenoid cystic carcinoma histology)
• Carcinoma of unknown primary with tumour infiltrating lymphocytes (TILs) and/or expressing PD-L1
• Mucosal melanoma
• Acral melanoma
• Osteosarcoma
• Undifferentiated pleomorphic sarcoma
• Clear cell carcinoma of the ovary
• Squamous cell carcinoma of the anal canal (SCCA)
• All patients must have a tumour tissue from their primary or metastatic tumour available
• Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).
• All patients must have at least one measurable lesion as defined by RECIST 1.1 that has not been the site of the protocol mandated biopsy. The criteria for defining measurable disease are as follows:
• CT scan (with slice thickness of 5 mm) ≥ 10 mm --\> longest diameter Lymph nodes by CT scan ≥ 15 mm --\> measured in short axis
• Patients must be ≥ 16 years of age.
• Patients must have an ECOG performance status of 0 or 1.

You may not qualify if:

• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other cancers curatively treated with no evidence of disease for ≥ 5 years.
• Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
• Patients with alopecia.
• Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).
• Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.
• History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of registration.
• Live attenuated vaccination administered within 30 days prior to registration.
• History of hypersensitivity to durvalumab or tremelimumab or any excipient. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.
• Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.
• Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.
• Concurrent treatment with other investigational drugs or anti-cancer therapy.
• Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (incl corticosteroid administration), or would put the patient at risk. This includes but is not limited to:
• History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
• Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).
• Active peptic ulcer disease or gastritis.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• AstraZeneca: collaborator

Study Sites (13)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• Gupta AA, Tinker A, Jonker D, Jamal R, Hirte H, Winquist EW, Chu Q, Kollmannsberger C, Wong R, Alcindor T, Nielsen TO, Tsao M, Cottrell TR, Provencher D, Hilton J, Krzyzanowska MK, Elser C, Hotte S, Sederias J, Zhang S, Tu W, Dancey J. Durvalumab and tremelimumab in patients with advanced rare cancer: a multi-centre, non-blinded, open-label phase II basket trial. EClinicalMedicine. 2024 Dec 10;79:102991. doi: 10.1016/j.eclinm.2024.102991. eCollection 2025 Jan.

  PMID: 39737219 RESULT

MeSH Terms

Interventions

durvalumab; tremelimumab

Results Point of Contact

• Title: Dr. Janet Dancey
• Organization: Canadian Cancer Trials Group

jdancey@ctg.queensu.ca

6135336000

Study Officials

• Abha Gupta

  Hospital for Sick Children, Toronto ON Canada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: December 14, 2016
• Primary Completion: June 20, 2021
• Study Completion: January 29, 2025
• Last Updated: March 7, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)