Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05849480
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-05-08
Brief Title:
A Study of CDX-1140 a CD40 Agonist in Combination With Capecitabine and Oxaliplatin CAPOX and Keytruda in Subjects With Biliary Tract Carcinoma BTC
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Study of CDX-1140 a CD40 Agonist in Combination With Capecitabine and Oxaliplatin CAPOX and Keytruda in Subjects With Biliary Tract Carcinoma BTC
Status:
RECRUITING
Status Verified Date:
2024-10-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Biliary tract carcinoma BTC is cancer of the slender tubes that carry fluids in the liver People with advanced BTC have few treatment options and their survival rates are very low
Objective
To test a study drug CDX-1140 combined 3 other drugs capecitabine oxaliplatin Keytruda in people with BTC
Eligibility
Adults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant
Design
Participants will be screened They will have a physical exam They will have blood tests and tests of their heart function They will have imaging scans They may need to have a biopsy A small sample of tissue will be taken from their tumor using a small needle
Three of the drugs are given through a tube attached to a needle inserted into a vein in the arm intravenous The fourth drug is a pill taken by mouth with water
Participants will be treated in 21-day cycles They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles After that they will receive intravenous treatments only on day 1 of each cycle
Participants will take the pill twice a day only for the first 2 weeks of each cycle They will stop taking this drug after 6 cycles
Imaging scans will be repeated every 9 weeks
Participants may continue receiving the study treatment for up to 2 years Follow-up visits including imaging scans will continue for 3 more years These images may be taken at other locations and sent to the researchers
Biliary tract carcinoma BTC is cancer of the slender tubes that carry fluids in the liver People with advanced BTC have few treatment options and their survival rates are very low
Objective
To test a study drug CDX-1140 combined 3 other drugs capecitabine oxaliplatin Keytruda in people with BTC
Eligibility
Adults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant
Design
Participants will be screened They will have a physical exam They will have blood tests and tests of their heart function They will have imaging scans They may need to have a biopsy A small sample of tissue will be taken from their tumor using a small needle
Three of the drugs are given through a tube attached to a needle inserted into a vein in the arm intravenous The fourth drug is a pill taken by mouth with water
Participants will be treated in 21-day cycles They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles After that they will receive intravenous treatments only on day 1 of each cycle
Participants will take the pill twice a day only for the first 2 weeks of each cycle They will stop taking this drug after 6 cycles
Imaging scans will be repeated every 9 weeks
Participants may continue receiving the study treatment for up to 2 years Follow-up visits including imaging scans will continue for 3 more years These images may be taken at other locations and sent to the researchers
Detailed Description:
Background
Advanced biliary tract carcinoma BTC has limited treatment options in the second line setting and a dismal prognosis
Capecitabine and oxaliplatin CAPOX in combination with Keytruda is a tolerable and potentially effective treatment for patients with refractory advanced BTC
Programmed cell death protein 1 PD-1 is an inhibitory receptor that is expressed by all Tcells during activation It regulates T-cell effector functions during various physiological responses including acute and chronic infection cancer and autoimmunity and immune
homeostasis Keytruda is a programmed death receptor-1 PD-1-blocking antibody indicated for the treatment of different cancers including patients with hepatocellular carcinoma
CD40-mediated activation of macrophages and dendritic cells DCs in intrahepatic cholangiocarcinoma iCCA significantly improves response to anti-PD-1 therapy in preclinical studies The efficacy of this regimen is enhanced by first-line chemotherapy
supporting the potential antitumor efficacy of the combination of CD40 agonist antibody anti-CD40 with anti-PD-1 and chemotherapy
Objectives
Phase I To estimate safe dose of CDX-1140 used in combination with CAPOX and Keytruda R
Phase II
To evaluate the 6-month progression free survival PFS in participants with advanced BTC treated with CDX-1140 CAPOX and Keytruda R
To determine the overall response rate ORR defined as complete response CR partial response PR according to RECIST 11 in participants with advanced BTC
Eligibility
Histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which together with the pathologyare highly suggestive of a diagnosis of BTC
Age 18 years
Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors RECIST 11
Design
Phase III single-arm non-randomized trial of KeytrudaR and CDX-1140 in combination with CAPOX in participants with BTC in the second-line setting
Initially 9-12 participants will be enrolled into a Phase I portion of the trial If safe we will continue enrollment as planned into Phase II if not we will close the protocol
After estimation of CDX-1140 recommended phase II dose the first 13 participants enrolled at this dose level of CDX-1140 in Phase I and Phase II will be evaluated for progression If among these 13 participants no more than 2 can be progression-free at the 6-months evaluation then no further participants will be enrolled as soon as this can be determined
Advanced biliary tract carcinoma BTC has limited treatment options in the second line setting and a dismal prognosis
Capecitabine and oxaliplatin CAPOX in combination with Keytruda is a tolerable and potentially effective treatment for patients with refractory advanced BTC
Programmed cell death protein 1 PD-1 is an inhibitory receptor that is expressed by all Tcells during activation It regulates T-cell effector functions during various physiological responses including acute and chronic infection cancer and autoimmunity and immune
homeostasis Keytruda is a programmed death receptor-1 PD-1-blocking antibody indicated for the treatment of different cancers including patients with hepatocellular carcinoma
CD40-mediated activation of macrophages and dendritic cells DCs in intrahepatic cholangiocarcinoma iCCA significantly improves response to anti-PD-1 therapy in preclinical studies The efficacy of this regimen is enhanced by first-line chemotherapy
supporting the potential antitumor efficacy of the combination of CD40 agonist antibody anti-CD40 with anti-PD-1 and chemotherapy
Objectives
Phase I To estimate safe dose of CDX-1140 used in combination with CAPOX and Keytruda R
Phase II
To evaluate the 6-month progression free survival PFS in participants with advanced BTC treated with CDX-1140 CAPOX and Keytruda R
To determine the overall response rate ORR defined as complete response CR partial response PR according to RECIST 11 in participants with advanced BTC
Eligibility
Histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which together with the pathologyare highly suggestive of a diagnosis of BTC
Age 18 years
Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors RECIST 11
Design
Phase III single-arm non-randomized trial of KeytrudaR and CDX-1140 in combination with CAPOX in participants with BTC in the second-line setting
Initially 9-12 participants will be enrolled into a Phase I portion of the trial If safe we will continue enrollment as planned into Phase II if not we will close the protocol
After estimation of CDX-1140 recommended phase II dose the first 13 participants enrolled at this dose level of CDX-1140 in Phase I and Phase II will be evaluated for progression If among these 13 participants no more than 2 can be progression-free at the 6-months evaluation then no further participants will be enrolled as soon as this can be determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001548-C | None | None | None |