18 and older, any sex, with Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response RatePrimary· up to 1 year
Overall response is evaluated using Response Evaluation Criteria in Solid Tumors criteria (RECIST 1.1). A participant is considered to have responded if they achieve either of the following outcomes:
* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm
* Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
0
Progression Free SurvivalSecondary· up to 1 year
Progression-Free Survival (PFS) is defined as the time from registration to the earlier of disease progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Disease progression is assessed using RECIST 1.1 criteria:
\- Progressive Disease(PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase o
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
49
40 – 96
Overall SurvivalSecondary· up to 1 year
Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive.
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
12
Treatment Emergent Adverse EventsSecondary· up to 1 year
Treatment emergent adverse events (TEAEs) are undesirable events not present prior to study treatment, or an already present event that worsens either in intensity or frequency following the treatment. TEAEs reported below were assessed as grade 3 or higher according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) guidelines.
Abdominal pain
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
2
Lymphopenia
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
2
Alanine aminotransferase (ALT) increased
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
1
Aspartate aminotransferase (AST) increased
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
1
Alkaline phosphatase increased
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
1
Dyspnea
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
1
Hypokalemia
Group
Value
95% CI
DKN 01 and Nivolumab Safety Run in
1
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This research is studying the effect of the combination of how two study drugs (Nivolumab and DKN-01) works in people with advanced biliary tract cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other recruiting trials for Biliary Tract Cancer
Currently open trials in the same condition.
NCT07221253 — A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Bili
· Phase 3
· recruiting
NCT06529718 — Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
· Phase 2
· recruiting
NCT07151118 — ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
· recruiting
NCT07142226 — Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC
· recruiting
NCT07135544 — A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initial
· Phase 2
· recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
· withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg
· NA
· not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
· NA
· not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries
· NA
· not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
· EARLY_PHASE1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04057365.