ARTEMIDE-Bil01: A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection

Sponsor

AstraZeneca (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06109779

Collaborator

(none)

750

Enrollment

Locations

Arms

81.7

Anticipated Duration (Months)

11.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Cancer	Drug: Rilvegostomig Drug: Placebo Drug: Capecitabine Drug: Gemcitabine/Cisplatin Drug: S-1 [Tegafur/Oteracil/gimeracil]	Phase 3

Detailed Description

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-blind masking

Primary Purpose:

Treatment

Official Title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Anticipated Study Start Date :

Dec 8, 2023

Anticipated Primary Completion Date :

Jun 29, 2029

Anticipated Study Completion Date :

Sep 30, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)	Drug: Rilvegostomig Rilvegostomig IV (intravenous) Q3W Drug: Capecitabine Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice 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 Drug: S-1 [Tegafur/Oteracil/gimeracil] S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles
Placebo Comparator: Arm B Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)	Drug: Placebo Placebo IV (intravenous) Q3W Drug: Capecitabine Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice 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 Drug: S-1 [Tegafur/Oteracil/gimeracil] S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Arm

Intervention/Treatment

Experimental: Arm A

Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Drug: Rilvegostomig

Rilvegostomig IV (intravenous) Q3W

Drug: Capecitabine

Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice

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

Drug: S-1 [Tegafur/Oteracil/gimeracil]

S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Placebo Comparator: Arm B

Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Drug: Placebo

Placebo IV (intravenous) Q3W

Drug: Capecitabine

Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice

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

Drug: S-1 [Tegafur/Oteracil/gimeracil]

S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Outcome Measures

Primary Outcome Measures

Recurrence free survival (RFS) for Arm A vs. Arm B [Approximately 5 years]
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Overall Survival (OS) for Arm A vs. Arm B [up to 7 years]
Overall survival is defined as the time from randomization until the date of death due to any cause.

Other Outcome Measures

Patient-reported tolerability Arm A vs. Arm B. [Up to approximately 7 years.]
Patient-reported tolerability is a multi-component endpoint defined as the proportion of participants in each arm reporting side effect bother, clinically meaningful impact on physical functioning and descriptive data on treatment-related symptoms.
Progression Free Survival (PFS) following recurrence Arm A vs. Arm B. [Up to approximately 7years]
Progression-free survival following recurrence is defined as the time from randomization until the earliest progression event after the start of the first subsequent therapy or death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)
Provision of a tumor sample collected at surgical resection.
Randomization within 12 weeks after resection with adequate healing and removal of drains.
Confirmed to be disease-free by imaging within 28 days prior to randomization.
Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion Criteria:

Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
Any anti-cancer therapy for BTC prior to surgery
Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
Current or prior use of immunosuppressive medication within 14 days before the first dose
Thromboembolic event within 3 months
Active HBV or HCV infection unless treated.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Clayton		Australia	3168
2	Research Site	Murdoch		Australia	6150
3	Research Site	Reservoir		Australia	3021
4	Research Site	Westmead		Australia	2145
5	Research Site	Natal		Brazil	59075-740
6	Research Site	Porto Alegre		Brazil	90035-000
7	Research Site	Porto Alegre		Brazil	91350-200
8	Research Site	Santa Maria		Brazil	97015-450
9	Research Site	Santo Andre		Brazil	09060-870
10	Research Site	Sao Paulo		Brazil	01246-000
11	Research Site	Sao Paulo		Brazil	01327-001
12	Research Site	Vitória		Brazil	29043-260
13	Research Site	Vancouver	British Columbia	Canada	V5Z 4E6
14	Research Site	Halifax	Nova Scotia	Canada	B3H 2Y9
15	Research Site	Kingston	Ontario	Canada	K7L 5P9
16	Research Site	Ottawa	Ontario	Canada	K1H 8L6
17	Research Site	Toronto	Ontario	Canada	M4N 3M5
18	Research Site	Toronto	Ontario	Canada	M5G 2M9
19	Research Site	Montreal	Quebec	Canada	H4A 3J1
20	Research Site	Berlin		Germany	13353
21	Research Site	Bonn		Germany	53127
22	Research Site	Essen		Germany	45122
23	Research Site	Frankfurt		Germany	60488
24	Research Site	Hamburg		Germany	22763
25	Research Site	Heidelberg		Germany	69120
26	Research Site	Luebeck		Germany	23538
27	Research Site	München		Germany	81377
28	Research Site	Ulm		Germany	89081
29	Research Site	Hong Kong		Hong Kong
30	Research Site	Shatin		Hong Kong	00000
31	Research Site	Delhi		India	110088
32	Research Site	Kolkata		India	700094
33	Research Site	Mysuru		India	570017
34	Research Site	New Delhi		India	110076
35	Research Site	Vadodara		India	391760
36	Research Site	Varanasi		India	221005
37	Research Site	Chuo-ku		Japan	104-0045
38	Research Site	Kitaadachi-gun		Japan	362-0806
39	Research Site	Nagoya-shi		Japan	464-8681
40	Research Site	Osaka-shi		Japan	541-8567
41	Research Site	Yokohama-shi		Japan	241-8515
42	Research Site	Kaohsiung		Taiwan	82445
43	Research Site	Kaohsiung		Taiwan	83301
44	Research Site	Taichung		Taiwan	40447
45	Research Site	Taichung		Taiwan	40705
46	Research Site	Tainan City		Taiwan	70403
47	Research Site	Taipei		Taiwan	10002
48	Research Site	Taipei		Taiwan	112
49	Research Site	Taoyuan		Taiwan	333
50	Research Site	Hat Yai		Thailand	90110
51	Research Site	Khon Kaen		Thailand	40002
52	Research Site	Muang		Thailand	34000
53	Research Site	Muang		Thailand	50200
54	Research Site	Naimuang		Thailand	30000
55	Research Site	Sisaket		Thailand	33000
56	Research Site	Ankara		Turkey	06100
57	Research Site	Ankara		Turkey	06230
58	Research Site	Ankara		Turkey	06620
59	Research Site	Antalya		Turkey	07100
60	Research Site	Erzurum		Turkey	25240
61	Research Site	Fatih-Istanbul		Turkey	34098
62	Research Site	Istanbul		Turkey	34722
63	Research Site	Samsun		Turkey
64	Research Site	Cambridge		United Kingdom	CB2 0QQ
65	Research Site	London		United Kingdom	NW3 2QG
66	Research Site	Manchester		United Kingdom	M20 4BX