A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

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A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Status
Active
Cancer Type
Gallbladder Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07221253
Protocol IDs
D702NC00001 (primary)
Study Sponsor
AstraZeneca Pharmaceuticals LP

Summary

The purpose of this study is to measure the efficacy and safety of rilvegostomig with
gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line
treatment for patients with advanced BTC.

Eligibility

  1. Key inclusion Criteria: - Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC). - Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting - Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample. - Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements. - ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization. - Adequate bone marrow and organ function. Key exclusion Criteria: - Ampullary carcinoma - Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC. - Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms. - Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study. - Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. - Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


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