Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

Browse trials for

• Cholangiocarcinoma 914

Keywords

• colony stimulating factor -1 receptor (CSF-1R) inhibitor
• Anti-PD-1 (receptor blocking antibody)
• Immunotherapy
• Intra-arterial therapy
• Y90 (yttrium-90 radioembolization)
• conventional transarterial chemoembolization (cTACE)
• Chemo-embolization
• Radio-embolization
• Biliary tract
• Intrahepatic Cholangiocarcinoma
• Monoclonal antibody

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's enrollment of 5 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Study arms

• Experimental
  Durvalumab and SNDX-6352

  Participants will receive Durvalumab and SNDX-6352.

  Drug: Durvalumab · Drug: SNDX-6352

Interventions

• DrugDurvalumab

  1. Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks). 2. Drug - 1500mg IV

  Also known as: MEDI4736

• DrugSNDX-6352

  1. SNDX-6352 - 3mg/kg via IV infusion over 30 minutes (-5/+10 min) on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1). 2. Drug - 3mg/kg IV

  Also known as: UCB6352

Primary outcomes

1. Objective Response Rate (ORR) Per mRECIST (Modified RECIST)

   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.

   Time frame: 8 months

2. Number of Participants Experiencing Study Drug-related Toxicities

   Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 5.0.

   Time frame: up to 1 year

Secondary outcomes

1. Overall Survival (OS)

   OS is defined as the number of months from the start of study treatment to time of death. Individuals are censored at the date of the last contact if no event occurs. The estimation method used was Kaplan-Meier.

   Time frame: up to 2 years

2. Progression-free Survival (PFS) Per mRECIST

   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.

   Time frame: 8 months

3. Duration of Response (DOR)

   Number of days from the start of partial response (PR) or complete response (CR) by radiographic scans, whichever is recorded first, until the first date that 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.

   Time frame: 8 months

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Feb 7, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No