Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IV Rilvegostomig, AZD2936
Rilvegostomig · 12 trials · 11 indications
Overall Survival is defined as time from randomization until the date of death due to any cause.
OS is defined as the time from randomization until the date of death due to any cause.
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
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.
To assess the safety and tolerability
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1
the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.
the proportion of participants alive and progression-free at 6 months.
Bioavailability based on AUCtau at first SC dose will be determined.
To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.
To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.
The OR is defined as a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR).
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Percentage of participants with AEs leading to discontinuation of rilvegostomig
The localized activity of injected microdoses will be analyzed using the NanoString GeoMx Digital Spatial Profiler (DSP) and the GeoMx Cancer Transcriptome Atlas to comprehensively profile over 1800 genes simultaneously with spatial resolution to describe tumor biology, the TME, and the immune response signatures of each drug at an injection site. DSP outcomes may be validated via IHC, immunofluorescence, or ISH technique.
| Arm | Type | Description |
|---|---|---|
| Control Arm | ACTIVE_COMPARATOR | Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) |
| Experimental Arm | EXPERIMENTAL | Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) |
| Arm A | EXPERIMENTAL | Drug: rilvegostomig |
| Arm B | ACTIVE_COMPARATOR | Drug: Pembrolizumab |
| Arm C | ACTIVE_COMPARATOR | Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin) |
| Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50% | EXPERIMENTAL | Participants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion |
| Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49% | EXPERIMENTAL | Participants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion |
| Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC | EXPERIMENTAL | Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion |
| Substudy 1 | EXPERIMENTAL | Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) |
| Substudy 2 | EXPERIMENTAL | Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) |
| Substudy 3 | EXPERIMENTAL | AZD0901 plus volrustomig and 5-fluorouracil or capecitabine |
| Substudy 4, Cohort 4a1 | EXPERIMENTAL | Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine |
| Substudy 4, Cohort 4a2 | EXPERIMENTAL | Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil |
| Substudy 4, Cohort 4b | EXPERIMENTAL | Sonesitatug vedotin (AZD0901) plus capecitabine |
| Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu | EXPERIMENTAL | Participants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with recombinant human hyaluronidase (rHu) and SC rilvegostomig (DL1) at predefined intervals. |
| Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu | EXPERIMENTAL | Participants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with rHu and SC rilvegostomig (DL2) at predefined intervals. |
| Part 2 (dose confirmation): SC Rilvegostomig and rHu | EXPERIMENTAL | Participants will receive SC rilvegostomig and rHu. |
| Sub study 2 Part A: Safety run-in | EXPERIMENTAL | Participants with squamous and non-squamous NSCLC will receive combination therapy of rilvegostomig, ramucirumab, and platinum-based chemotherapy to assess the safety and tolerability of this regimen. |
| Sub study 2 Part B: Dose expansion | EXPERIMENTAL | Participants will be randomised 1:1 into one of 2 treatment arms (rilvegostomig + chemotherapy + ramucirumab OR rilvegostomig + chemotherapy) in non-squamous histology cohorts and into a single arm (rilvegostomig + chemotherapy+ ramucirumab) in squamous histology cohorts. |
| Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC) | EXPERIMENTAL | Rilvegostomig Intravenous (IV) monotherapy |
| Dose Expansion Part B: CPI experienced NSCLC | EXPERIMENTAL | Rilvegostomig IV monotherapy |
| Dose Expansion Part C: CPI Naive NSCLC | EXPERIMENTAL | Rilvegostomig IV monotherapy |
| Dose Expansion Part D: CPI Naive NSCLC | EXPERIMENTAL | Rilvegostomig IV monotherapy |
| Dose Expansion Part E: treatment Naive Squamous NSCLC | EXPERIMENTAL | Rilvegostomig IV monotherapy |
| Rilvegostomig, Volrustomig, Sabestomig, AZD9592, Pembrolizumab | EXPERIMENTAL | HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, AZD9592, and pembrolizumab as single agents and AZD9592 drug combinations with the evaluated biologics. |
| Name | Type | Description |
|---|---|---|
| Rilvegostomig | DRUG | Rilvegostomig IV (intravenous) Q3W |
| Durvalumab | DRUG | Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W. |
| Gemcitabine/Cisplatin | DRUG | Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle |
| Pembrolizumab | BIOLOGICAL | Administered intravenously (IV) on Day 1 of each 21-day cycle |
| Trastuzumab deruxtecan | DRUG | Q3W, intravenous infusion |
| Trastuzumab | DRUG | Q3W, intravenous infusion |
| 5-fluorouracil | DRUG | Q3W, intravenous infusion |
| Capecitabine | DRUG | BID, oral administration |
| Cisplatin | DRUG | Q3W, intravenous infusion |
| Oxaliplatin | DRUG | Q3W, intravenous infusion |
| Carboplatin | DRUG | Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles |
| Pemetrexed | DRUG | Administered as one intravenously (IV) on Day 1 of each 21-day cycle |
| Paclitaxel | DRUG | Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles |
| Nab-paclitaxel | DRUG | Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles |
| Placebo | DRUG | Placebo IV (intravenous) Q3W |
| S-1 [Tegafur/Oteracil/gimeracil] | DRUG | 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 |
| Ramucirumab | DRUG | Ramucirumab will be administered as IV infusion. |
| Dato-DXd | DRUG | Dato-DXd will be administered as IV infusion. |
| Volrustomig | DRUG | an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion |
| FOLFOX | DRUG | 5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available) |
| XELOX | DRUG | capecitabine and oxaliplatin |
| AZD0901 | DRUG | an anti Claudin18.2 ADC; IV infusion |
| IV Rilvegostomig | DRUG | Rilvegostomig administered IV. |
| Recombinant Human Hyaluronidase (rHu) | DRUG | rHu administered subcutaneously. |
| SC Rilvegostomig | DRUG | Rilvegostomig administered subcutaneously. |
| SC rilvegostomig + rHu | DRUG | SC rilvegostomig + rHu administered subcutaneously. |
| AZD2936 | DRUG | Anti-TIGIT/Anti-PD-1 Bispecific Antibody |
| Sabestomig | BIOLOGICAL | Intratumoral microdose injection by the CIVO device. |
| AZD9592 | BIOLOGICAL | Intratumoral microdose injection by the CIVO device. |
| AZD9592 + Rilvegostomig | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| AZD9592 + Volrustomig | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| AZD9592 + Sabestomig | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| AZD9592 + Pembrolizumab | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
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 ...
Rilvegostomig is an investigational oncology therapy being developed by AstraZeneca PLC for the treatment of advanced solid tumors and several specific cancer types. It is being studied in non-small cell lung cancer, biliary tract cancer, gastric cancer, and HER2-positive gastric cancer. It remains in clinical development and is not approved for commercial use.
Rilvegostomig is being evaluated for advanced solid tumors, advanced or metastatic non-small cell lung cancer, biliary tract cancer, gastric cancer, and HER2-positive gastric cancer. These are investigational uses studied in clinical trials, not approved indications. Treatment settings include first-line biliary tract cancer and previously treated advanced solid tumors.
Rilvegostomig is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is sponsoring the clinical trial program evaluating the drug across multiple cancer types and treatment settings, including combinations with chemotherapy and other agents.
Rilvegostomig is in clinical development spanning Phase 1 through Phase 3. The Phase 3 ARTEMIDE-Biliary02 study is recruiting, alongside Phase 1 and Phase 2 studies in non-small cell lung cancer and advanced solid tumors. It is investigational and has not been approved by the FDA.
Rilvegostomig is being studied in four recruiting trials: NCT07221253, a Phase 3 trial in first-line biliary tract cancer; NCT07161414, a Phase 1 subcutaneous pharmacokinetics and safety study in advanced solid tumors; NCT07098338, a Phase 2 novel combination study in non-small cell lung cancer; and NCT06996782, a Phase 1 platform study in advanced or metastatic non-small cell lung cancer.
Yes, IV Rilvegostomig is another name for Rilvegostomig. The IV designation refers to intravenous administration. A separate Phase 1 trial, NCT07161414, is evaluating a subcutaneous formulation of Rilvegostomig in adults with advanced solid tumors previously treated with standard of care therapy.