Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma

A Phase IIa Clinical Trial of First-Line Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for Advanced Biliary Tract Cancers With FGFR2 Alterations

This phase II trial tests how well giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib for the treatment of biliary tract cancer with FGFR2 alterations that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemigatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. Giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib may work well for the treatment of unresectable, locally advanced or metastatic biliary tract cancer with FGFR2 alterations.

Study Overview

• Status: Recruiting
• Conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage III Gallbladder Cancer AJCC v8; Unresectable Gallbladder Carcinoma; Locally Advanced Gallbladder Carcinoma; Metastatic Gallbladder Carcinoma; Stage IV Gallbladder Cancer AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8; Stage IV Distal Bile Duct Cancer AJCC v8; Unresectable Intrahepatic Cholangiocarcinoma; Metastatic Intrahepatic Cholangiocarcinoma; Stage III Distal Bile Duct Cancer AJCC v8; Stage III Ampulla of Vater Cancer AJCC v8; Stage IV Ampulla of Vater Cancer AJCC v8; Metastatic Biliary Tract Carcinoma; Locally Advanced Intrahepatic Cholangiocarcinoma; Unresectable Biliary Tract Carcinoma; Locally Advanced Biliary Tract Carcinoma; Locally Advanced Extrahepatic Cholangiocarcinoma; Metastatic Extrahepatic Cholangiocarcinoma; Unresectable Extrahepatic Cholangiocarcinoma; Locally Advanced Ampulla of Vater Carcinoma; Metastatic Ampulla of Vater Carcinoma; Unresectable Ampulla of Vater Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Drug: Cisplatin; Drug: Gemcitabine; Biological: Durvalumab; Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: Computed Tomography; Drug: Pemigatinib

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of cyclical therapy alternating with chemoimmunotherapy and pemigatinib in patients with advanced cholangiocarcinoma and FGFR2 fusions and rearrangements, or other gain-of function alterations involved in FGFR.

SECONDARY OBJECTIVES:

I. To further evaluate the tumor response and other clinical benefits of cyclical therapy alternating with chemoimmunotherapy and pemigatinib.

II. To characterize the safety and tolerability of cyclical therapy alternating with chemoimmunotherapy and pemigatinib.

EXPLORATORY OBJECTIVES:

I. To evaluate liquid biopsy findings during cyclical therapy using a novel FGFR focused cell free deoxyribonucleic acid (DNA) (cfDNA) assay.

II. Measure change patterns of quality of life (QoL) with standard questionnaires and correlative with clinical outcomes during cyclical therapy.

OUTLINE: Patients alternate between the chemoimmunotherapy (CIO) block and the FGFR inhibitor (FGFRi) block.

CIO BLOCK: Patients receive cisplatin intravenously (IV), over 60 minutes, and gemcitabine IV, over 30 minutes, on days 1 and 15 and durvalumab IV, over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 2 cycles for each block, in the absence of disease progression or unacceptable toxicity.

FGFRi BLOCK: Patients receive pemigatinib orally (PO) daily (QD) on days 1-14 of each cycle. Cycles repeat every 21 days for 3 cycles for each block, in the absence of disease progression or unacceptable toxicity.

If no progression after FGFRi, treatment will be switched to CIO block. If CIO has been completely discontinued due to prior failures or unacceptable toxicity, patients may continue treatment with pemigatinib until unacceptable toxicity, disease progression, treatment is discontinued at the discretion of investigator or withdrawal of consent, or death. If tumor progressed after the first CIO block, but disease was controlled after the following FGFRi block, switching to one more chemoimmunotherapy block is allowed. If pemigatinib has been completely discontinued due to prior failures or unacceptable toxicity, patients may continue treatment with chemoimmunotherapy until the patient experiences unacceptable toxicity, disease progression, treatment is discontinued at the discretion of investigator or withdrawal of consent, or death. Patients come off study if tumor progressed after both initial chemoimmunotherapy block and FGFR inhibitor block or if no evidence of disease after the therapy, but patient is willing to switch to maintenance therapy.

Patients undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days and every 3 months for 2 years then every 6 months until 5 years.

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Sameek Roychowdhury, MD, PhD; Phone Number: 614-685-5842; Email: Sameek.Roychowdhury@osumc.edu
      • Principal Investigator: Sameek Roychowdhury, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults 18 years of age or older with histologically or cytologically confirmed unresectable locally advanced or metastatic carcinoma of the biliary tract, including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder, and ampulla of Vater, at the time of diagnosis
• Patients must have tumors classified as having FGFR2 gene fusion/rearrangements or other gain-of function alterations involved in FGFR as detected by any analytically validated, Clinical Laboratory Improvement Act (CLIA)-certified molecular testing, including commercial tests (Foundation Medicine, Caris, Tempus, Guardant360, and others) or other platforms of next generation sequencing. Gene rearrangements are structural variants that can include inversions, translocations, duplications, and truncations. In addition, all patients will have tumor specimens sent and stored centrally
• Patients are permitted to have received one 21-day or 28-day cycle of either gemcitabine/cisplatin or gemcitabine/cisplatin with immunotherapy (either durvalumab or pembrolizumab) prior to inclusion in trial, and this will count as the first cycle in the schematic
• One or more measurable lesions per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients with ECOG performance status of 2 may be considered on a case-by-case basis by Principal Investigator
• Life expectancy of greater than 4 months
• Ability to understand and participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits

• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3)

  • Note: Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection

• Platelets ≥ 75 × 109/L

  • Note: Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection

• Hemoglobin ≥ 90 g/L (9 g/dL)

  • Note: Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection
• Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) are all ≤ 1.5 × upper limits of normal (ULN), with the exception of patients taking blood thinners with coagulation factor elevation associated with these drugs
• Serum bilirubin ≤ 1.5 × ULN (≤ 5 × ULN if the tumor involves the liver), unless associated with patient's primary cancer and/or metastases and with Principal Investigator's approval; biliary drains and stents are acceptable
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤ 3 × ULN (if with liver metastases, AST and ALT ≤ 5 × ULN), unless associated with patient's primary cancer and/or metastases and with Principal Investigator's approval; biliary drains and stents are acceptable
• Creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula)
• Patients with an inherited cancer syndrome or a medical/family history suggestive of an inherited cancer syndrome are eligible

• Recovery from adverse events of previous systemic anti-cancer therapies to baseline or grade 1, except for:

  • alopecia
  • stable neuropathy of ≤ grade 2 due to prior cancer therapy
• Able to swallow and retain oral medication

• Patients who are human immunodeficiency virus (HIV) positive may participate IF they meet the following eligibility requirements:

  • They must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks.
  • They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression.
  • For patients who have received chemotherapy in the previous one month, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy.
  • They must have an undetectable viral load and a CD4 count ≥ 250 cells/mcL within 7 days of enrollment.
  • They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. HIV-infected patients will be monitored every 12 weeks for viral load and CD4 counts
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of hepatitis B surface antigen [HbsAg]) are eligible
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)

Exclusion Criteria:

• Received any definitive radiotherapy, targeted therapy, immunotherapy, or any investigational therapies within 13 days of the first study drug administration. Patients are permitted to have received one 21- or 28-day cycle of either gem/cis or gemcitabine/cisplatin/durvalumab prior to inclusion in trial, and this will count as the first cycle in the schematic. Localized palliative radiation therapy (should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted
• Patients who have not recovered from reversible toxicity of prior anti-tumor therapy (except toxicities which are not clinically significant such as alopecia, grade 0-2 neuropathy)
• Patients who received prior FGFR-targeted therapy
• Within 2 weeks before the first dose of study drug, the subject's calcium and phosphate level continuing to exceed the ULN despite medical treatment
• Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, or medical conditions that increase their risk of developing hyperphosphatemia or hypercalcemia
• History and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung, with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification
• Patients with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)

• Current evidence of corneal or retinal abnormalities that may increase eye toxicity, including but not limited to:

  • Currently suffering from central serous retinopathy (CSR) or retinal vein occlusion (RVO), or with relevant history;
  • Active wet age-related macular degeneration (wAMD);
  • Diabetic retinopathy with macular edema;
  • Uncontrollable glaucoma;
  • Keratopathy, such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
• Consumed or anticipate consuming diet or drugs known to be strong or moderate cytochrome P450 (CYP) 3A4 inhibitors, strong CYP3A4 inducers or strong inhibitors of efflux transports including P-gp and BCRP for 28 days (or 5 half-lives, whichever is shorter) before the first dose of study drug or during the study drug treatment
• Patients with active or prior documented autoimmune or inflammatory disorders
• Participants must not have an active, known or suspected autoimmune disease which may affect vital organ function or has/may require systemic immunosuppressive therapy for management. Participants with inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]) are also excluded with the exception of the following: participants with type I diabetes mellitus, hypothyroidism (e.g. following Hashimoto syndrome) only requiring and stable on hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (such as celiac disease controlled by diet) are permitted to enroll. Patients without active disease for 5 years may also be enrolled after consultation with the study physician

• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:

  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection);
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

• Receipt of live attenuated vaccine within 30 days of planned start of study therapy.

  • Note: Patients, if enrolled, should not receive live vaccine while receiving immunotherapy and up to 30 days after the last dose of immunotherapy
• Must not have prior history of organ transplantation, allogeneic transplantation, or double umbilical cord transplantation
• Active hepatitis B virus (HBV DNA < ULN is required if HBs-Ag or HBc-Ab is positive), active hepatitis C, or uncontrolled HIV infection
• Known allergy or hypersensitivity to any study treatment
• Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of study drug
• Patients with brain metastases or metastases elsewhere within the central nervous system (CNS) are excluded
• Patients with unresolved spinal cord compression

• Clinically significant, uncontrolled intercurrent illness including, but not limited to:

  • Acute symptomatic or active infection requiring systemic therapy and medical intervention (e.g., IV antibiotics and/or hospitalization);
  • Psychiatric illness and/or social situations that would limit compliance with completion of study requirements or ability to give informed consent

• Has a history of uncontrolled cardiovascular diseases including:

  • Known New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months before the first dose of study drug;
  • Arrhythmias requiring treatment at screening;
  • Left ventricular ejection fraction (LVEF) < 50% at screening;
  • Clinically significant prolonged QTc interval, or QTc interval > 470 ms in women and > 450 ms in men at screening;
  • Cerebrovascular accident within 6 months before the first dose of study drug
• History of active bleeding within 6 months, signs of portal hypertension leading to gastric esophageal venous bleeding within 2 months before the first dose of study drug, or the investigator believes that there is uncontrolled bleeding (such as bleeding esophageal varices, local active ulcer lesions, etc.)
• At the investigator's discretion, with evidence of severe or uncontrolled systemic disease (such as unstable or non-compensatory lung, liver, or kidney disease); or any unstable systemic disease (including active clinically severe infections, uncontrolled hypertension, or liver, kidney, or metabolic disease)
• Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from screening to 6 months after the last study drug administration; fertile men who are unwilling or unable to perform contraception from screening to at least 6 months after the last study drug administration
• History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study or affect survival
• Any other medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
• History of hypovitaminosis D requiring supraphysiologic doses (e.g., 50,000 IU/weekly) to replenish the deficiency. Vitamin D supplements are allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (chemoimmunotherapy, FGFRi cycles); See Detailed Description

Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Drug: Cisplatin; Given IV; Other Names: CDDP; Cis-diamminedichloridoplatinum; Cismaplat; Cisplatinum; Neoplatin; Platinol; Abiplatin; Blastolem; Briplatin; Cis-diammine-dichloroplatinum; Cis-diamminedichloro Platinum (II); Cis-diamminedichloroplatinum; Cis-dichloroammine Platinum (II); Cis-platinous Diamine Dichloride; Cis-platinum; Cis-platinum II; Cis-platinum II Diamine Dichloride; Cisplatina; Cisplatyl; Citoplatino; Citosin; Cysplatyna; DDP; Lederplatin; Metaplatin; Peyrone's Chloride; Peyrone's Salt; Placis; Plastistil; Platamine; Platiblastin; Platiblastin-S; Platinex; Platinol- AQ; Platinol-AQ; Platinol-AQ VHA Plus; Platinoxan; Platinum; Platinum Diamminodichloride; Platiran; Platistin; Platosin; Drug: Gemcitabine; Given IV; Other Names: dFdCyd; dFdC; Difluorodeoxycytidine; Biological: Durvalumab; Given IV; Other Names: Imfinzi; Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer; MEDI-4736; MEDI4736; MEDI 4736; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Other: Survey Administration; Ancillary studies; Procedure: Computed Tomography; Undergo CT scan; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type; Drug: Pemigatinib; Given PO; Other Names: INCB054828; Pemazyre; INCB 054828; INCB-054828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Defined as the date of start of treatment to the date of death due to any cause. Will be analyzed using the Kaplan Meier method. Survival rate at 12 months and median OS will be estimated along with 95% confidence intervals from the Kaplan Meier distribution.	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		Up to 5 years
Duration of response		Up to 5 years
Overall response rate (ORR)	Defined as complete response (CR) + partial response (PR). Assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The estimated ORR will be presented along with the corresponding 95% confidence interval for each cohort, based on a binomial distribution.	Up to 5 years
Disease control rate	Defined as CR + PR + stable disease. Assessed by investigator as per RECIST v 1.1.	Up to 5 years
Duration of therapy (DOT)	The median DOT will be presented along with the corresponding 95% confidence interval for each cohort, based on a binomial distribution.	From start of cyclical therapy to termination of cyclical therapy, up to 5 years
Progression free survival (PFS)	Kaplan-Meier analysis of PFS will be conducted for each cohort.	From start of treatment to the event defined as the first documented progression or death due to any cause, up to 5 years
Percentage of patients who discontinue therapy		Up to 5 years
Percentage of patients who go on to receive second line treatment		Up to 5 years
Patient quality of life	Patient quality of life will be measured by the European Organization for Research and Treatment of Cancer Quality of Life EORTC QLQ-C30. The EORTC QLQ-30 consists of 30 questions and is scored on 10 sub scales. Each subscale score ranges from 0-100. For functional and quality of life subscales a higher score indicates better function and quality of life. For the symptoms subscales higher scores represent worse symptoms. Changes over time will be analyzed using a linear mixed model.	Up to 5 years
Incidence of adverse events (AE)	Type, frequency, and severity, assessed with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v 5.0.	Up to 5 years
Incidence of serious adverse events	Type, frequency, and severity, assessed with NCI CTCAE, v 5.0.	Up to 5 years
Dose interruptions	The number of dose interruptions experienced by patients will be summarized	Up to 5 years
Dose reductions	The number of times a dose reduction is required for a patient will be summarized	Up to 5 years
Dose intensity	The ratio of actual dose received and actual duration will be listed and summarized by means of descriptive statistics	Up to 5 years
Incidence of AE leading to study drug delay or discontinuation		Up to 5 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Incyte Corporation
• Investigators: Principal Investigator: Sameek Roychowdhury, MD, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 5, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Gallbladder Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Elements; Metals; Chemistry Techniques, Analytical; Spectrum Analysis; Metals, Heavy; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Hydrogen Sulfide; Platinum Compounds; Transition Elements; Gemcitabine; Immunoglobulin G; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Specimen Handling; Magnetic Resonance Spectroscopy; durvalumab; Disulfides; Platinum; pemigatinib
• Other Study ID Numbers: OSU-25058; NCI-2026-05653 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No