Rilvegostomig History and Updates

90 events · 2010 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
90
Trial Milestones
0
Pivotal Publications
Rilvegostomig — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20102011201220132014201520162017201820192020202120222023202420252026202720282029203020312032Trial: NCT07431281 2026-02-03 → 2029-08-16 (primary completion)Trial: NCT07221253 2025-12-04 → 2029-07-04 (primary completion)Trial: NCT07161414 2025-11-25 → 2027-07-19 (primary completion)Trial: NCT06996782 2025-11-24 → 2029-02-23 (primary completion)Trial: NCT07128290 2025-10-30 → 2029-04-30 (primary completion)Trial: NCT07098338 2025-08-07 → 2029-04-06 (primary completion)Trial: NCT07115043 2025-07-29 → 2029-10-02 (primary completion)Trial: NCT07069712 2025-07-17 → 2027-01-28 (primary completion)Trial: NCT06921785 2025-05-06 → 2029-03-16 (primary completion)Trial: NCT06868277 2025-04-10 → 2030-01-17 (primary completion)Trial: NCT06989112 2025-03-27 → 2029-01-19 (primary completion)Trial: NCT06764875 2025-03-01 → 2029-04-27 (primary completion)Trial: NCT06630130 2025-01-22 → 2028-10-30 (primary completion)Trial: NCT06569225 2024-12-15 → 2027-12-31 (primary completion)Trial: NCT06627647 2024-11-27 → 2029-05-10 (primary completion)Trial: NCT06692738 2024-11-18 → 2029-02-05 (primary completion)Trial: NCT06564844 2024-10-15 → 2027-06-30 (primary completion)Trial: NCT06467357 2024-08-12 → 2028-06-12 (primary completion)Trial: NCT06366451 2024-05-22 → 2025-02-28 (primary completion)Trial: NCT06357533 2024-04-11 → 2029-12-28 (primary completion)Trial: NCT06109779 2023-12-04 → 2029-01-02 (primary completion)Trial: NCT05775159 2023-04-24 → 2026-10-27 (primary completion)Trial: NCT05702229 2023-01-16 → 2027-11-30 (primary completion)Trial: NCT05489211 2022-09-06 → 2027-10-01 (primary completion)Trial: NCT05061550 2022-04-14 → 2030-05-28 (primary completion)Trial: NCT05123482 2021-10-18 → 2027-09-29 (primary completion)Trial: NCT04541108 2021-07-26 → 2031-12-31 (primary completion)Trial: NCT04686305 2021-03-09 → 2027-06-30 (primary completion)Trial: NCT04379596 2020-06-03 → 2027-06-01 (primary completion)Trial: NCT01042379 2010-03-01 → 2030-12-31 (primary completion)today (2026-06-16)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-16Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Rilvegostomig since 2010, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05775159
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07069712
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenoca
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04379596
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06564844
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, F
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04686305
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous N
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07161414
A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previo
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05489211
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05702229
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06109779
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06989112
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expre
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06692738
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06921785
Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carc
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06764875
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positi
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06627647
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07221253
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07431281
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gast
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06357533
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expres
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06868277
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07431281
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gast
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07221253
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07161414
A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previo
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07128290
PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07069712
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenoca
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06921785
Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carc
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06868277
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06989112
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expre
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06764875
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positi
Primary completion· ClinicalTrials.gov
EARLY_Phase 1 primary completion: NCT06366451
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
2024
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06627647
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06692738
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06564844
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, F
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06467357
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Trial started· ClinicalTrials.gov
EARLY_Phase 1 trial started: NCT06366451
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06357533
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expres
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06109779
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05775159
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05702229
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
2022
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05489211
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
2021
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04686305
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous N
2020
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04379596
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
2010

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.