Trial Outcomes & Findings for Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC) (NCT NCT04989218)

Last Updated: 2024-11-05

Results Overview

We will obtain computerized tomography (CT) and/or magnetic resonance imaging (MRI) scans to assess the response to the intervention agents. We are interested in determining the percentage of patients who achieve a complete response or partial response (complete response plus partial response equals to objective response) when treated with intervention agents.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Assessments will occur after 2 cycles (6 weeks) of receiving treatment and after 4 cycles (12 weeks) of receiving treatment or before surgical resection, whichever happens first.

Results posted on

2024-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Novel Combination of Chemotherapy and Immunotherapy This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab). Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles. Novel combination of chemotherapy and immunotherapy: This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novel Combination of Chemotherapy and Immunotherapy n=1 Participants This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab). Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles. Novel combination of chemotherapy and immunotherapy: This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	43 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: Assessments will occur after 2 cycles (6 weeks) of receiving treatment and after 4 cycles (12 weeks) of receiving treatment or before surgical resection, whichever happens first.

Population: The study terminated prematurely due to slow accrual and study sponsor decision.

Outcome measures

Outcome measures
Measure	Novel Combination of Chemotherapy and Immunotherapy n=1 Participants This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab). Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles. Novel combination of chemotherapy and immunotherapy: This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
Objective Response Rate	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline through 16 weeks of treatment

We will assess the percentage of patients who receive all 4 cycles of preoperative therapy

Outcome measures

Outcome measures
Measure	Novel Combination of Chemotherapy and Immunotherapy n=1 Participants This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab). Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles. Novel combination of chemotherapy and immunotherapy: This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
The Percentage of Participants That Complete Preoperative Therapy	1 Participants

SECONDARY outcome

Timeframe: Baseline through 16 weeks of treatment

Adverse reactions will be monitored and documented based on the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. The percentage of patients who experience different grades of adverse events will be assessed

Outcome measures

Outcome measures
Measure	Novel Combination of Chemotherapy and Immunotherapy n=1 Participants This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab). Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles. Novel combination of chemotherapy and immunotherapy: This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
Determine the Safety of the Combination of Intervention Agents by Assessing the Percentage of Patients Who Experience Dose Limiting Toxicities or Develop Adverse Reactions	1 Participants

SECONDARY outcome

Timeframe: Baseline through 24 months

Population: this was not evaluated on any participants enrolled

We will compare the differences in the patterns between the responders and the non responders.

Outcome measures

Outcome data not reported

Adverse Events

Novel Combination of Chemotherapy and Immunotherapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Novel Combination of Chemotherapy and Immunotherapy n=1 participants at risk This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab). Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles. Novel combination of chemotherapy and immunotherapy: This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
Gastrointestinal disorders hospitalization	100.0% 1/1 • Number of events 1 • 16 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mehmet Akce, Associate Professor

The University of Alabama at Birmingham

Phone: 2059342992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place