Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02643303
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2015-12-18
Brief Title:
A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Phase 12 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab MEDI4736 Plus the Toll-like Receptor Agonist Poly-ICLC in Subjects With Advanced Measurable Biopsy-accessible Cancers
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter Phase 12 study of the CTLA-4 antibody tremelimumab and the PD-L1 antibody durvalumab MEDI4736 in combination with the tumor microenvironment TME modulator poly-ICLC a TLR3 agonist in subjects with advanced measurable biopsy-accessible cancers
Detailed Description:
This is an open-label multicenter Phase 12 study of the cytotoxic T-lymphocyte-associated antigen-4 CTLA-4 antibody tremelimumab and the programmed cell death ligand-1 PD-L1 antibody durvalumab MEDI4736 in combination with the tumor microenvironment TME modulator poly-ICLC a toll-like receptor 3 TLR3 agonist in subjects with advanced measurable biopsy-accessible cancers Subjects will receive intratumoral and intramuscular IM administration of poly-ICLC and intravenous IV administration of durvalumab together with either IV or intratumoral administration of tremelimumab The study will be conducted in 2 phases
Phase 1 There will be enrollment to 3 subject cohorts in Phase 1 with staggered initiation of enrollment
Cohort 1A IV Durvalumab IntratumoralIM Poly-ICLC After safety is demonstrated in the first 3-6 subjects in Cohort 1A Cohorts 1B and 1C will open to enrollment
Cohort 1B IV Durvalumab IV Tremelimumab IntratumoralIM Poly-ICLC
Cohort 1C IV Durvalumab Intratumoral Tremelimumab IntratumoralIM Poly-ICLC
Phase 2 Upon determination of the recommended combination dose in Cohort 1C up to 66 evaluable subjects will be treated in Phase 2 Up to 6 subjects will be initially enrolled by tumor type head and neck squamous cell carcinoma locally recurrent or metastatic breast cancer sarcoma Merkel cell carcinoma cutaneous T-cell lymphoma melanoma after failure of available therapies genitourinary cancers and solid tumors with accessible metastases Subjects enrolled in Cohort 1C will be included in Phase 2 in the applicable tumor type Data from all subjects in each Phase 2 tumor type will be reviewed for safetyefficacy to select up to 3 tumor types that demonstrate an efficacy signal defined as at least 1 of 6 subjects within a tumor type who achieve a partial response PR or complete response CR by immune-related RECIST irRECIST or RECIST 11 or stable disease SD for at least 6 months Up to 6 additional subjects in each of the selected tumor types may be enrolled in the expansion
Phase 1 There will be enrollment to 3 subject cohorts in Phase 1 with staggered initiation of enrollment
Cohort 1A IV Durvalumab IntratumoralIM Poly-ICLC After safety is demonstrated in the first 3-6 subjects in Cohort 1A Cohorts 1B and 1C will open to enrollment
Cohort 1B IV Durvalumab IV Tremelimumab IntratumoralIM Poly-ICLC
Cohort 1C IV Durvalumab Intratumoral Tremelimumab IntratumoralIM Poly-ICLC
Phase 2 Upon determination of the recommended combination dose in Cohort 1C up to 66 evaluable subjects will be treated in Phase 2 Up to 6 subjects will be initially enrolled by tumor type head and neck squamous cell carcinoma locally recurrent or metastatic breast cancer sarcoma Merkel cell carcinoma cutaneous T-cell lymphoma melanoma after failure of available therapies genitourinary cancers and solid tumors with accessible metastases Subjects enrolled in Cohort 1C will be included in Phase 2 in the applicable tumor type Data from all subjects in each Phase 2 tumor type will be reviewed for safetyefficacy to select up to 3 tumor types that demonstrate an efficacy signal defined as at least 1 of 6 subjects within a tumor type who achieve a partial response PR or complete response CR by immune-related RECIST irRECIST or RECIST 11 or stable disease SD for at least 6 months Up to 6 additional subjects in each of the selected tumor types may be enrolled in the expansion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None