Phase 2
Completed N=37
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Source: ClinicalTrials.gov NCT00378482 ↗Enrolled (actual)
37
Serious AEs
10.8%
Results posted
May 2021
Primary outcomePrimary: Safety Endpoints: Serious Adverse Events to Tremelimumab. — 4; 33 Participants
Summary
This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Endpoints: Serious Adverse Events to Tremelimumab. |
4; 33 | — |
| PRIMARY Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab. |
4; 33 | — |
| PRIMARY Safety Endpoints: Hypersensitivity Reactions to Tremelimumab. |
6; 31 | — |
| PRIMARY Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) |
19; 17; 1 | — |
| PRIMARY Efficacy Endpoints: Survival |
10; 27 | — |
| SECONDARY Disease Free Survival |
3.0 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must have already received tremelimumab in another protocol
- Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
- Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00378482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.