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Trial Title:
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
NCT ID:
NCT06001658
Condition:
Pancreatic Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Gemcitabine
Pembrolizumab
Conditions: Keywords:
Biliary Tract cancer
Pembrolizumab
Gemcitabine
Cisplatin
Immunotherapy
Potentially resectable biliary tract cancer
Anti PD-L1
PD-L1
Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Patients will receive treatment on Day 1 and Day 8 of each cycle. Gemcitabine (1000
mg/m2) will be administered IV on Day 1 and Day 8 of each cycle, Q3 weeks with 2 - 4
cycles prior to surgery and then 4-6 cycles after surgery.
Arm group label:
Gemcitabine, Cisplatin and Pembrolizumab
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Patients will receive treatment on Day 1 and Day 8 of each cycle. Cisplatin (25 mg/m2)
will be administered IV on Day 1 and Day 8 of each cycle, Q3 weeks with 2 - 4 cycles
prior to surgery and then 4-6 cycles after surgery.
Arm group label:
Gemcitabine, Cisplatin and Pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Patients will receive treatment on Day 1 of each cycle. Pembrolizumab (200 mg) will be
administered IV on Day 1 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and
then 4-6 cycles after surgery. Pembrolizumab (400 mg) will be administered IV Q6 weeks up
to 4 cycles as maintenance.
Arm group label:
Gemcitabine, Cisplatin and Pembrolizumab
Other name:
KEYTRUDA; anti-PD-1 mAb
Summary:
The purpose of this study is to determine the safety of peri-operative gemcitabine,
cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of
gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to
pathologic responses.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including
gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
- Resectable BTC (biliary tract cancer)
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Age ≥18 years.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
- Patients must have adequate organ and marrow function defined by study-specified
laboratory tests.
- Patients must have adequate liver function defined by study-specified laboratory
tests.
- Patients with chronic or acute HBV or HCV infection must have disease controlled
prior to enrollment.
- Women of childbearing potential (WOCBP) must have a negative urine or serum
pregnancy test.
- For both Women and Men, must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Receiving, or previously received, any systemic chemotherapy, or investigational
agent for BTC.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
- Have been diagnosed with another cancer or myeloproliferative disorder whose natural
history or treatment has the potential to interfere with safety or efficacy
assessment of this study's investigational drugs.
- Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
- Has active co-infection with HBV and HDV.
- Has a diagnosis of immunodeficiency.
- Has active autoimmune disease that has required systemic treatment in the past 2
years.
- Systemic or topical corticosteroids at immunosuppressive doses.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Prior tissue or organ allograft or allogeneic bone marrow transplantation, including
corneal transplants.
- Uncontrolled intercurrent active medical and/or psychiatric illness/social
psychosocial problems that that would limit compliance with study requirements.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled
infection, symptomatic congestive heart failure, unstable angina, cardiac
arrhythmia, metastatic cancer, or psychiatric illness/social situations that would
limit compliance with study requirements.
- Evidence of clinical ascites.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that
required steroids or has current pneumonitis/interstitial lung disease.
- Previously identified allergy or hypersensitivity to monoclonal antibodies or any
component of the study treatment formulations.
- Pregnant or breastfeeding.
- WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
- Subjects unable to undergo venipuncture and/or tolerate venous access.
- Patient is at the time of signing informed consent a regular user (including
"recreational use") of any illicit drugs or had a recent history (within the last
year) of substance abuse (including alcohol).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SKCCC Johns Hopkins
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colleen Apostol, RN
Phone:
410-614-3644
Email:
GIClinicalTrials@jhmi.edu
Contact backup:
Last name:
Joann Santmyer, RN
Phone:
410-614-3644
Email:
GIClinicalTrials@jhmi.edu
Investigator:
Last name:
Marina Baretti, MD
Email:
Principal Investigator
Start date:
July 8, 2024
Completion date:
June 2028
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001658
