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Biliary Tract Neoplasms

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Biliary Tract Diseases

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Biliary Tract Cancer

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Keytruda, oxaliplatin, capecitabine and escalating doses of CDX-1140

Keytruda, oxaliplatin, capecitabine and estimated safe dose of CDX-1140

Oxaliplatin (130 mg/m2) will be administered IV on Day 1 of each cycle, every 21 days (up to 6 cycles).

oxaliplatin

Capecitabine (750 mg/m2 every 12 hours) will be administered orally with an intermittent schedule: 2 weeks on, 1 week off, of each cycle, every 21 days (up to 6 cycles).

capecitabine

Pembrolizumab (200 mg) will be given IV on Day 8 of each cycle every 21 days (up to 6 cycles).

Keytruda

CDX-1140 (0.36-1.5 mg/kg; per assigned dose level) will be given IV on Day 8 of each cycle every 21 days (up to 6 cycles).

CDX-1140

Donna M Hrones, C.R.N.P.

Maria C Monge Bonilla, M.D.

National Cancer Institute Referral Office

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.

...

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 (DC)s 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 1.1 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 pathology,are highly suggestive of a diagnosis of BTC

Age \>=18 years

Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Design:

Phase I/II, single-arm, non-randomized trial of Keytruda(R) 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 forprogression. 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.

A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)

A Phase I/II Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)

.All IPD recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.

Estimation of safe dose will be determined based on number of dose limiting toxicities (DLTs) experienced.

6-month PFS probability will be calculated using the Kaplan-Meier method.

The fraction of participants who experience a response (PR + CR) evaluated every 9 (+/- 4) weeks. Results will be reported along with 80% and 95% two-sided confidence intervals.

Any adverse events/toxicities identified will be reported by type and grade.

Participants will be assessed for survival at study visits while on study therapy and annually thereafter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)	NCT05849480	Biliary Cancer Bile Duct Cance... Cancer of the B...	oxaliplatin capecitabine Keytruda CDX-1140	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)	NCT05849480	Biliary Cancer Bile Duct Cance... Cancer of the B...	oxaliplatin capecitabine Keytruda CDX-1140	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)

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