| CTRI Number |
CTRI/2024/02/063127 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
ARTEMIDE-Biliary01 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| D7025C00001 V1.0 27 Jul 2023 |
Protocol Number |
| NCT06109779 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Sandeep AV |
| Designation |
Senior Director, Oncology Country Head, Oncology Site Management and Monitoring India |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd
Block N1 12th Floor Manyata Embassy Business Park
Rachenahalli Outer Ring Road Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845079472 |
| Fax |
|
| Email |
sandeep.av@astrazeneca.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Sandeep AV |
| Designation |
Senior Director, Oncology Country Head, Oncology Site Management and Monitoring India |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd
Block N1 12th Floor Manyata Embassy Business Park
Rachenahalli Outer Ring Road Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845079472 |
| Fax |
|
| Email |
sandeep.av@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sandeep AV |
| Designation |
Senior Director, Oncology Country Head, Oncology Site Management and Monitoring India |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd
Block N1 12th Floor Manyata Embassy Business Park
Rachenahalli Outer Ring Road Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845079472 |
| Fax |
|
| Email |
sandeep.av@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| 151 85 Sodertalje, Sweden |
| AstraZeneca AB |
|
|
Primary Sponsor
|
| Name |
AstraZeneca AB |
| Address |
151 85 Södertälje Sweden a member of the AstraZeneca group |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AstraZeneca Pharma India Ltd |
Block N1, 12th Floor, Manyata Embassy Business Park
Rachenahalli, Outer Ring Road, Bangalore – 560045, India
|
|
|
Countries of Recruitment
|
Australia
Belgium
Brazil
Canada
China
Denmark
France
Germany
Hong Kong
India
Italy
Japan
Norway
Poland
Republic of Korea
Spain
Taiwan
Thailand
Turkey
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinivas K G |
Bharath Hospital |
Bharath Hospital and Institute of Oncology, No. 438, Outer Ring Road, Hebbal Industrial Area, Lakshmikanth Nagar, Mysore - 570 017, Karnataka
Mysore
KARNATAKA |
9663121728
drsrinivaskg2020@gmail.com |
| Dr Vineet Govinda Gupta |
Fortis Hospital |
Fortis Hospital, Shalimar Bagh, A Block, New Delhi - 110088
New Delhi
DELHI |
9911152107
vineet.gupta1@fortishealthcare.com |
| Dr Manish Kumar Singhal |
Indraprastha Apollo Hospitals |
Indraprastha Apollo Hospitals,
Sarita Vihar, Mathura Road, New Delhi - 110076
New Delhi
DELHI |
9818736533
singhaloncocare@yahoo.co.in |
| Dr Santhosh Vandanasetti |
Kailash Cancer Hospital & Research Centre |
Kailash Cancer Hospital & Research Centre, Muniseva Ashram, Goraj, Waghodiya, Vadodara - 391760, Gujarat
Vadodara
GUJARAT |
9427423693
vandanasetti.santhosh@greenashram.org |
| Dr Anuj Gupta |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi - 221005, Uttar Pradesh
Varanasi
UTTAR PRADESH |
9588229594
dr.anuj.gupta24@gmail.com |
| Dr Poulami Basu |
Netaji Subash Chandra Bose Cancer Hospital |
Netaji Subash Chandra Bose Cancer Hospital, 3081, Nayabad, New Garia, Kolkata, 700094, West Bengal
Kolkata
WEST BENGAL |
8902444454
poulami_basu23@yahoo.co.in |
| Dr Vineet Talwar |
Rajiv Gandhi Cancer Institute and Research Centre |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, New Delhi – 110085
New Delhi
DELHI |
9810241512
drvineettalwar@yahoo.com |
| Dr Vikas Sureshchand Ostwal |
Tata Memorial Hospital |
Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai-400012, Maharashtra
Mumbai
MAHARASHTRA |
9702288801
dr.vikas.ostwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee N.S.C.B.C Research Institute, Netaji Subhash Chandra Bose Cancer Hospital |
Approved |
| IEC - Kailash Cancer Hospital & Research Centre |
Approved |
| Institutional Ethics Committee - Clinical Studies, Indraprastha Apollo Hospitals |
Approved |
| Institutional Ethics Committee - I & II, TATA Memorial Hospital |
Approved |
| Institutional Ethics Committee Fortis Hospital |
Approved |
| Institutional Ethics Committee, Bharath Hospital and Institute of Oncology |
Approved |
| Institutional Ethics Committee, MPMMCC and HBCH, Varanasi, Mahamana Pandit Madan Mohan Malaviya Cancer Center |
Approved |
| Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
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 |
| Intervention |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1 Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)
2 Provision of a tumor sample collected at surgical resection.
3 Randomization within 12 weeks after resection with adequate healing and removal of drains.
4 Confirmed to be disease-free by imaging within 28 days prior to randomization.
5 Eastern Cooperative Oncology Group performance status of 0 or 1 |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1 Participants with locally advanced, unresectable, or metastatic disease at initial diagnosis.
2 Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
3 Any anti-cancer therapy for BTC prior to surgery
4 Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
5 Current or prior use of immunosuppressive medication within 14 days before the first dose
6 Thromboembolic event within 3 months
7 Active HBV or HCV infection unless treated. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ] |
Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Survival (OS) for Arm A vs. Arm B [ Time Frame: up to 7 years ] |
Overall survival is defined as the time from randomization until the date of death due to any cause. |
| Patient-reported tolerability Arm A vs. Arm B [ Time Frame: 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. [ Time Frame: Up to approximately 7 years. ] |
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. |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/12/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="30"
Months="10"
Days="23" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
|