Unresectable Intrahepatic CholangiocarcinomaPhase 2NCT04301778
Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Durvalumab and SNDX-6352 in people with Unresectable Intrahepatic Cholangiocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Intrahepatic Cholangiocarcinoma
- What is being tested?
- Durvalumab and SNDX-6352
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2021to 6 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Child Pugh Class A
- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula.
- Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
- Must use acceptable form of birth control while on study.
- Men must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
- Willing and able to comply with the protocol for the duration of the study
Who cannot join
- 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.
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- 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.
- History of leptomeningeal carcinomatosis.
- Brain metastases or spinal cord compression.
- History of active primary immunodeficiency.
- Infection with Tuberculosis, HIV or hepatitis B or C at screening.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Pregnant or breastfeeding women.
- Has a history of allergy to study treatments or any of its components of the study.
- Prior randomization or treatment in a previous durvalumab and/or SNDX-6532 clinical study regardless of treatment arm assignment.
- Patient has clinically significant heart disease.
- Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.
- Unwilling or unable to follow the study schedule for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
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.
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.
- Being tested
- Durvalumab, SNDX-6352
- 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
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
- Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks).
- Drug - 1500mg IV
SNDX-6352Drug
Also called UCB6352
- 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).
- Drug - 3mg/kg IV
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab and SNDX-6352 | Experimental | Participants will receive Durvalumab and SNDX-6352. Receives: Drug: Durvalumab; Drug: SNDX-6352 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
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.
Measured: up to 1 year
Secondary outcomes (3)
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.
Measured: up to 2 years
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.
Measured: 8 months
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start24 Aug 2021
- Primary completion4 Nov 2022
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unresectable Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Syndax Pharmaceuticals, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Lei Zheng, MD, Principal investigator, Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301778
- Sponsor's protocol ID
- J2031
- Other IDs
- IRB00233351
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2020
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04301778
- Acronym / sponsor ID
- J2031
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Syndax Pharmaceuticals, AstraZeneca
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab and SNDX-6352 | Experimental | Drug: Durvalumab, Drug: SNDX-6352Participants will receive Durvalumab and SNDX-6352. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI47361. 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 | Drug | Durvalumab and SNDX-6352 |
| SNDX-6352Also: UCB63521. 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 | Drug | Durvalumab and SNDX-6352 |
Primary outcome
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.
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: up to 2 years
Progression-free Survival (PFS) Per mRECIST
Time frame: 8 months
Duration of Response (DOR)
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Zheng, MD principal investigator
Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and SNDX-6352 in people with Unresectable Intrahepatic Cholangiocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Per mRECIST (Modified RECIST) (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.