- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724890
Study of Avelumab-M3814 Combinations
November 29, 2022 updated by: EMD Serono Research & Development Institute, Inc.
A Multicenter, Open-Label, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination With Avelumab With and Without Palliative Radiotherapy in Participants With Selected Advanced Solid Tumors
The main purpose of the study is to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute, Inc
-
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center
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New York
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Lake Success, New York, United States, 11041
- Mount Sinai - PRIME (10707)
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-
Ohio
-
Cincinnati, Ohio, United States, 45267-0502
- UC Health Clinical Trials Office (10702)
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center - Stephenson Cancer Center
-
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Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center Health System
-
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South Carolina
-
Greenville, South Carolina, United States, 29605
- Greenville Hospital System University Medical Center (ITOR)
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt-Ingram Cancer Center (8867)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Part A and Part FE (M3814 + avelumab): Participants must have histologically or cytologically proven advanced or metastatic solid tumors for which no standard therapy exists, standard therapy has failed, or participants are intolerant to or have rejected established therapy known to provide clinical benefit for their condition
- Part B (M3814 + Radiotherapy [RT] + avelumab): histologically or cytologically proven advanced or metastatic solid tumors for which no standard therapy exists, standard therapy has failed, or participants are intolerant to or have rejected established therapy known to provide benefit for their condition and are amenable to receive RT
- Part A, B and FE: Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at study entry
- Part A, B and FE: Female participants of childbearing potential should be willing to use a highly effective contraceptive method
- Part A, B and FE: Male participants should agree to refrain from donating sperm plus, either: abstain from any activity that allows for exposure to ejaculate
- Use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
- Part A, B and FE: Be willing to provide informed consent for the trial
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Participants who have received prior chemotherapy, hormonal anticancer therapy with the exception of luteinizing hormone-releasing hormone analogs, biologic therapy, or any other anticancer therapy within 28 days of the first dose of study treatments (6 weeks for nitrosoureas or mitomycin C)
- Participants who have undergone major surgery for any reason, except diagnostic biopsy, within 4 weeks of the study intervention and/or has not fully recovered from the surgery within 4 weeks of the study intervention
- Participants with evidence of active or history of autoimmune disease that might deteriorate when receiving an immune-stimulatory agent
- Participants with brain metastases, except those meeting the following criteria: a) brain metastases that have been treated locally and are clinically stable for greater than or equal to (>=) 4 weeks prior to randomization b) no ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) c) participants must be either off steroids or on a stable or decreasing dose of less than (<) 10 milligrams (mg) daily prednisone (or equivalent)
- Participants with severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year), psychiatric or substance abuse disorders; or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results
- Participants requiring systemic immunosuppressive agents (such as steroids) for any reason who cannot be tapered off these drugs before start of study intervention, with the following exceptions: a) participants with adrenal insufficiency, may continue corticosteroids at physiologic replacement dose, equivalent to less than or equal to (<=) 10 mg prednisone daily b) participants requiring steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, or inhalation) is permitted c) participants with previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon planned to be completed in 14 days, or that the dose after 14 days will be equivalent to <= 10 mg prednisone daily
- Participants with a history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Hepatitis B virus or Hepatitis C and with history of infection must have a polymerase chain reaction (PCR) documentation that infection is cleared
- Participants who have received a live vaccine within 30 days prior to the first dose of trial treatment
- Participants with known prior severe hypersensitivity to any of the investigational products or any component in its formulations
- Participants with evidence of additional malignancy within the last 5 years unless a complete remission without further recurrence was achieved at least 2 years prior to study entry and participants were deemed to have been cured with no additional therapy required or anticipated to be required. Participants with treated nonmelanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate may participate
- Participants pretreated with immunotherapy who have, any history of dose limiting toxicities (DLTs) with prior immunotherapy agents, including Grade 3/4 immune-related adverse events (irAEs); irreversible irAEs; Grade greater than or equals to (>=) 3 irAEs that did not respond to steroid rescue; or neurologic irAE with significant clinical sequelae
- Participants with irAE requiring hormone replacement therapy (e.g., thyroxine, insulin, or physiologic dose of corticosteroid replacement therapy for adrenal or pituitary insufficiency) may participate as long as the endocrinopathy is well controlled and the participant is not otherwise symptomatic from hormone insufficiency
- Physiologic corticosteroid dose is defined as <= 10 mg daily of prednisone or equivalent
- for Part B only:
- Participants who have confirmed esophagitis and in whom radiation planning target volume will include any portion of the esophagus, the participant is not eligible unless an esophageal endoscopy rules out the presence of esophagitis
- Participants in whom more than 10 percent (%) of the total esophagus volume might receive more than 15 gray (Gy) (50% of the prescribed radiotherapy [RT] dose)
- Participants who have had previous radiotherapy to the same region as intended to be irradiated in this study within the past 12 months
- Participants who have had extensive previous radiotherapy on >= 30% of bone marrow reserve or prior bone marrow/stem cell transplantation within 5 years before study start
- If participant hepatic metastatic lesion is selected to be irradiated: - the non-tumor liver volume < 700 milli liters (mL); - Child-Pugh score >= 8
- Other protocol defined exclusion criteria could apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Part A: M3814 + Avelumab
|
Participants will receive M3814 twice daily (BID) continuously starting from Day 1 until progressive disease (PD) or unacceptable toxicity.
Other Names:
Participants will receive M3814 concomitantly with RT once (QD) daily starting Day 1 for 5 days per week for 2 weeks in total.
Other Names:
Participants will receive avelumab once every 2 weeks (Q2W) starting from Day 1 until PD or unacceptable toxicity.
|
EXPERIMENTAL: Part B: M3814 + Avelumab + Radiotherapy (RT)
|
Participants will receive M3814 twice daily (BID) continuously starting from Day 1 until progressive disease (PD) or unacceptable toxicity.
Other Names:
Participants will receive M3814 concomitantly with RT once (QD) daily starting Day 1 for 5 days per week for 2 weeks in total.
Other Names:
Participants will receive avelumab once every 2 weeks (Q2W) starting from Day 1 until PD or unacceptable toxicity.
Participants will receive radiotherapy at the dose of 3 grays (Gy) per day starting Day 1 for 5 days per week for 2 weeks.
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EXPERIMENTAL: Part FE: M3814 + Avelumab (fasted/fed state)
|
Participants will receive M3814 twice daily (BID) continuously starting from Day 1 until progressive disease (PD) or unacceptable toxicity.
Other Names:
Participants will receive M3814 concomitantly with RT once (QD) daily starting Day 1 for 5 days per week for 2 weeks in total.
Other Names:
Participants will receive avelumab once every 2 weeks (Q2W) starting from Day 1 until PD or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: Occurrence of Dose-limiting Toxicities (DLTs)
Time Frame: From first study intervention to planned final assessment at 3 weeks
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From first study intervention to planned final assessment at 3 weeks
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Part B: Occurrence of Dose-limiting Toxicities (DLTs)
Time Frame: From first study intervention to planned final assessment at 4 weeks
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From first study intervention to planned final assessment at 4 weeks
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Part FE: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of M3814
Time Frame: Pre-dose up to end of treatment at 268 days
|
Pre-dose up to end of treatment at 268 days
|
Part FE: Maximum Observed Drug Concentration (Cmax) of M3814
Time Frame: Pre-dose up to end of treatment at 268 days
|
Pre-dose up to end of treatment at 268 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part A, B and FE: Occurrence of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and Serious Adverse Events
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
|
Part A, B and FE: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, Physical Examination, Electrocardiogram (ECG) Findings
Time Frame: From the first study intervention to planned final assessment at 508 days
|
Number of participants with clinically significant abnormalities will be reported.
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From the first study intervention to planned final assessment at 508 days
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Part A, B and FE: Number of Participants With Status Assessed on Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
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Part A and B: Maximum Observed Drug Concentration (Cmax) of Avelumab
Time Frame: Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
|
Part A and B: Minimum Observed Drug Concentration (Cmin) of Avelumab
Time Frame: Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
|
Part A and B: Accumulation Ratio for Cmax [Racc(Cmax)] of Avelumab
Time Frame: Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
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Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
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Part A and B: Accumulation Ratio for AUC [Racc (AUC)] of Avelumab
Time Frame: Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
|
Part A and B: Apparent Terminal Half-life (t1/2) of Avelumab
Time Frame: Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
Part A: Pre-dose up to end of treatment at 299 days; Part B: Pre-dose up to end of treatment at 451 days
|
|
Part A and B: Maximum Observed Drug Concentration (Cmax) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
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Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
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Part A and B: Time to Reach the Maximum Plasma Concentration (tmax) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Minimum Observed Drug Concentration (Cmin) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Average Plasma Concentration of M3814 Observed Post-dose (Cavg)
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Fluctuation Index of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Accumulation ratio for Cmax [Racc(Cmax)] of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A: Accumulation ratio for AUC [Racc(Auc)] of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A: Apparent Terminal Half-life (t1/2) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Apparent Volume of Distribution During Terminal Phase (Vz/f) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Apparent Clearance (CL/f) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A and B: Terminal Elimination Rate Constant (λz) of M3814
Time Frame: Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
Part A: Pre-dose up to end of treatment at 268 days; Part B: Pre-dose up to end of treatment at 343 days
|
|
Part A, B and FE: Number of Participants With Positive Antidrug Antibody (ADA) Assay
Time Frame: Part A and FE: From the first study intervention to planned final assessment at 299 days; Part B: From the first study intervention to planned final Part B assessment at 451 days
|
Part A and FE: From the first study intervention to planned final assessment at 299 days; Part B: From the first study intervention to planned final Part B assessment at 451 days
|
|
Part A, B and FE: Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1)
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
|
Part A, B and FE: Duration of Response (DOR) as Assessed by the Investigators According to RECIST v 1.1
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
|
Part A, B and FE: Progression-free Survival (PFS) Time According to RECIST v 1.1 Assessed by Investigator
Time Frame: Part A and FE: From baseline to planned final assessment at 305 days; Part B: From baseline to planned final assessment at 473 days
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Part A and FE: From baseline to planned final assessment at 305 days; Part B: From baseline to planned final assessment at 473 days
|
|
Part A, B and FE: Tumor size Based on Investigator Assessment According to RECIST v 1.1
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
|
Part A, B and FE: Overall Survival
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
|
Part B: Number of Participants with Radiotherapy (RT)-induced Toxicity According to NCI-CTCAE v 5.0
Time Frame: From the first study intervention to planned final assessment at 508 days
|
From the first study intervention to planned final assessment at 508 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 27, 2018
Primary Completion (ACTUAL)
September 1, 2021
Study Completion (ACTUAL)
August 17, 2022
Study Registration Dates
First Submitted
October 29, 2018
First Submitted That Met QC Criteria
October 29, 2018
First Posted (ACTUAL)
October 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 29, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS201964_0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.
Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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