CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
Durvalumab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically/cytologically confirmed advanced, metastatic, recurrent, or unresectable cancer (specific types: salivary carcinoma excluding adenoid cystic; carcinoma of unknown primary with TILs and/or PD-L1 expression; mucosal melanoma; acral melanoma; osteosarcoma; undifferentiated pleomorphic sarcoma; clear cell ovarian carcinoma; squamous cell anal carcinoma) with no curative therapy available
  • Tumor tissue from primary or metastatic tumor must be available
  • At least one measurable lesion by RECIST 1.1 (CT ≥10 mm longest diameter, or lymph node ≥15 mm short axis)
  • Age ≥16 years
Key exclusion· 8
  • Prior PD-1/PD-L1 inhibitor (including durvalumab) or CTLA-4 inhibitor (including tremelimumab) therapy
  • Active or prior autoimmune/inflammatory disorders (IBD, diverticulitis, celiac disease, SLE, sarcoidosis, Wegener syndrome, rheumatoid arthritis, hypophysitis, uveitis) within 3 years, with exceptions for alopecia, Grave's disease, vitiligo/psoriasis not requiring systemic treatment, and stable hypothyroidism
  • History of primary immunodeficiency or allogeneic organ transplant requiring immunosuppression
  • Live attenuated vaccination within 30 days prior to registration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02879162
NCT02879162Phase 2Completed

A Phase II Study of Durvalumab and Tremelimumab in Patients With Advanced Rare Tumours

Canadian Cancer Trials Group·interventional·Posted Aug 25, 2016·Updated Mar 7, 2025

In Brief

A Phase 2 clinical trial evaluating Durvalumab and Tremelimumab for Advanced Rare Tumours. Completed, enrolled 140 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartDec 14, 2016
Primary CompletionJun 20, 2021
Study CompletionJan 29, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.9 years ago

Interventions

Durvalumabdrug

Tremelimumabdrug