Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Wi… (NCT02537418) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens
Canada153 participantsStarted 2015-10-16
Plain-language summary
The purpose of this study is to find the highest dose of durvalumab or of durvalumab with tremelimumab that can be tolerated without causing very severe side effects when receiving standard chemotherapy and to see what effects the study drugs has on this type of cancer. Patients may receive durvalumab alone or in combination with tremelimumab.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically and/or cytologically confirmed cancer that is advanced / metastatic / recurrent or unresectable and for which no curative therapy exists.
* Patients must be considered suitable candidates for and eligible to receive one of the regimens (including durvalumab and tremelimumab alone (dose level 5) included in this protocol and which is open to accrual. For each regimen, specific criteria for registration may be applicable to the cohort/dose level to ensure tolerability in the planned phase II or III trials. Centres must confirm that the planned cohort is open to accrual and whether there are any restrictions on tumour types prior to approaching patients.
* For etoposide/carboplatin regimen, patients must have untreated small cell lung cancer (SCLC).
* If a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) is available, patients must have provided informed consent for the release of the block. All patients must have provided informed consent for correlative studies.
* 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). Patients ideally should have measurable disease.
* Patients must have an ECOG performance status of 0, 1, or 2 (0 or 1 for untreated SCLC enrolled to etoposide/carboplatin). Patients with PS 2 must be considered fit for first line cytotoxic or…
What they're measuring
1
Confirm the recommended phase II dose (RP2D) of durvalumab ± tremelimumab in patients receiving standard chemotherapy