H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Biliary Carcinoma or Gall Bladder Carcinoma. 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.
Progression Free Survival (PFS)Primary· 6 months
PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the 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
Group
Value
95% CI
Combination Therapy
6.2
2.9 – 10.1
Response RateSecondary· Up to 24 months
Complete Response + Partial Response according to RECIST 1.1. 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 the diameters of target lesions, taking as reference the baseline sum diameters.
Partial Response
Group
Value
95% CI
Combination Therapy
31.6
Stable Disease
Group
Value
95% CI
Combination Therapy
57.9
Overall Survival (OS)Secondary· Up to 24 months
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Group
Value
95% CI
Combination Therapy
13.7
6.8 – 18.0
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Combination Therapy
Serious: 12/24 (50%)
Deaths: 18/24
Serious adverse events (26 terms)
Reaction
System
Combination Therapy
Abdominal Pain
Gastrointestinal disorders
—
Ascites
Gastrointestinal disorders
—
Sepsis
Infections and infestations
—
Blood bilirubin increased
Investigations
—
Anemia
Blood and lymphatic system disorders
—
Colitis
Gastrointestinal disorders
—
Colonic obstruction
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Gastrointestinal disorders -Other
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Edema limbs
General disorders
—
Fatigue
General disorders
—
Pain
General disorders
—
Cholecystitis
Hepatobiliary disorders
—
Gallbladder obstruction
Hepatobiliary disorders
—
Hepatic infection
Hepatobiliary disorders
—
Infections and Infestations - Other
Infections and infestations
—
Lung infection
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Platelet count decreased
Investigations
—
Anorexia
Metabolism and nutrition disorders
—
Dehydration
Metabolism and nutrition disorders
—
Neoplasms benign, malignant and unspecified - Other
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Urinary tract obstruction
Renal and urinary disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (123 terms — click to expand)
The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07195734 — Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
· Phase 2
· recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
· Phase 2
· not yet recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
Other H. Lee Moffitt Cancer Center and Research Institute trials
Trials by the same sponsor.
NCT05041335 — Wet Heparinized Suction for Abdominal Cancer
· NA
· not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs
· NA
· recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors
· Phase 1
· recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
· Phase 2
· recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC
· Phase 1
· 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 H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 4 August 2021
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/NCT02631590.