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.
Overview
- Phase
- Phase 2
- Intervention
- Durvalumab
- Conditions
- Unresectable Intrahepatic Cholangiocarcinoma
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Study Drug-related Toxicities
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
The purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a CSF-1R inhibitor (SNDX-6352) in people with Intrahepatic Cholangiocarcinoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have cytologically confirmed intrahepatic cholangiocarcinoma.
- •All disease must be localized to the liver (locally advanced).
- •Subjects must not be deemed surgical candidates.
- •Must be a candidate for conventional transarterial chemoembolization or yttrium-90 radioembolization.
- •Must have measureable disease be mRECIST. Measurable disease will be confirmed by radiological imaging (MRI, CT).
- •Age ≥18 years
- •Body weight \> 30 kg
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Life expectancy ≥12 weeks.
- •Patient must have adequate organ function defined by the study-specified laboratory tests as per the protocol.
Exclusion Criteria
- •Candidate for surgical resection
- •Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up of an interventional study.
- •Major surgery within 4 weeks prior to initiation of study treatment.
- •Received the last dose of anticancer therapy ≤ 28 days prior to the first dose of study drug.
- •All toxicities NCI CTCAE Grade ≥2 attributed to prior anti-cancer therapy other than alopecia, vitiligo, and neuropathy.
- •Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
- •History of allogenic organ transplantation.
- •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, checkpoint inhibitor-induced immune mediated reaction or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]).
- •Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements.
- •History of known additional primary malignancies.
Arms & Interventions
Durvalumab and SNDX-6352
Participants will receive Durvalumab and SNDX-6352.
Intervention: Durvalumab
Durvalumab and SNDX-6352
Participants will receive Durvalumab and SNDX-6352.
Intervention: SNDX-6352
Outcomes
Primary Outcomes
Number of Participants Experiencing Study Drug-related Toxicities
Time Frame: up to 1 year
Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 5.0.
Objective Response Rate (ORR) Per mRECIST (Modified RECIST)
Time Frame: 8 months
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.
Secondary Outcomes
- Overall Survival (OS)(up to 2 years)
- Progression-free Survival (PFS) Per mRECIST(8 months)
- Duration of Response (DOR)(8 months)