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

Purpose

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.

Condition

  • Biliary Tract Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open label

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control Arm 		Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
  • Drug: Durvalumab
    Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
    Other names:
    • IMFINZI
  • Drug: Gemcitabine/Cisplatin
    Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
Experimental
Experimental Arm 		Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
  • Drug: Rilvegostomig
    Rilvegostomig IV (intravenous) Q3W
    Other names:
    • AZD2936
  • Drug: Gemcitabine/Cisplatin
    Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Recruiting Locations

Research Site
Phoenix, Arizona 85054

Research Site
Tucson, Arizona 85719

Research Site
Duarte, California 91010

Research Site
Orange, California 92868

Research Site
Palo Alto, California 94304

Research Site
Aurora, Colorado 80045

Research Site
New Haven, Connecticut 06510

Research Site
Gainesville, Florida 32610

Research Site
Jacksonville, Florida 32224

Research Site
Marietta, Georgia 30060

Research Site
Louisville, Kentucky 40217

Research Site
Baltimore, Maryland 21231

Research Site
Rochester, Minnesota 55905

Research Site
Santa Fe, New Mexico 87505

Research Site
Providence, Rhode Island 02903

Research Site
Pierre, South Dakota 57501

Research Site
Sioux Falls, South Dakota 57105

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com