Durvalumab in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT04301778|
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Intrahepatic Cholangiocarcinoma||Drug: Durvalumab Drug: SNDX-6352||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Durvalumab (MEDI4736) in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma.|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2024|
Experimental: Durvalumab and SNDX-6352
Participants will receive Durvalumab and SNDX-6352.
Other Name: MEDI4736
Other Name: UCB6352
- Objective Response Rate (ORR) per mRECIST (modified RECIST) [ Time Frame: 4 years ]ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (mRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
- Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]When calculating the incidence of Adverse Events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
- Overall survival (OS) [ Time Frame: 4 years ]OS will be measured from date of first dose until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
- Progression-free Survival (PFS) per mRECIST [ Time Frame: 4 years ]PFS is defined as the number of months from the date of treatment to disease recurrence [disease recurrence (DR) progressive disease (PD) or relapse from complete response (CR) as assessed using mRECIST criteria] or death due to any cause. Per mRECIST criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
- Duration of Response (DOR) [ Time Frame: 4 years ]Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per mRECIST, CR = disappearance of any intratumoral arterial enhancement in all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301778
|Contact: Susan Sartorius-Mergenthaler, RN||410-614-3644||Sartosu@jhmi.edu|
|Contact: Ellen Lilly-Forman, RNemail@example.com|
|Principal Investigator:||Lei Zheng, MD||Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution|