Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as volrustomig
MEDI5752 · 13 trials · 17 indications
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.
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 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.
OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
PFS24 is defined as the Kaplan-Meier estimate of PFS at 24 months per RECIST 1.1 or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
PFS is defined as the time from randomization until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) or death due to any cause.
Number of participants who received at least one dose of study treatment will be assessed.
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1.
Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v5.0.
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib. A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0.
The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline.
The primary safety endpoint is assessed by the change in vital signs from baseline.
The primary safety endpoint is as assessed by the change in ECG parameters from baseline.
The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib.
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
The primary endpoint of antitumor activity include Objective Response and will be based on all post baseline disease assessments that occur prior to initiation of subsequent anticancer therapy.
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.
| Arm | Type | Description |
|---|---|---|
| Study Arm | EXPERIMENTAL | Participants in this arm will receive volrustomig. |
| Observation Arm | NO_INTERVENTION | Patients in this arm will undergo observation. |
| Volrustomig + Carboplatin + pemetrexed | EXPERIMENTAL | Volrustomig in combination with carboplatin plus pemetrexed |
| Investigator's choice of standard care | ACTIVE_COMPARATOR | The investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology. |
| Arm 1 | EXPERIMENTAL | Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion |
| Arm 2 | ACTIVE_COMPARATOR | Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion |
| Volrustomig | EXPERIMENTAL | Volrustomig |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Volrustomig + FOLFIRI+ Bevacizumab group (Arm A) | EXPERIMENTAL | Participants will receive FOLFIRI and bevacizumab together with volrustomig. |
| FOLFIRI+ BEVACIZUMAB group (Arm B) | ACTIVE_COMPARATOR | Partcipants will receive FOLFIRI and bevacizumab. |
| Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed | EXPERIMENTAL | Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed. |
| Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed | EXPERIMENTAL | Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed. |
| Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel | EXPERIMENTAL | Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel). |
| Sub-study 1 | EXPERIMENTAL | Volrustomig monotherapy |
| Sub-study 2 | EXPERIMENTAL | Volrustomig monotherapy |
| Sub-study 3 Arm A | EXPERIMENTAL | Volrustomig in combination with carboplatin plus paclitaxel |
| Sub-study 3 Arm B | EXPERIMENTAL | Volrustomig in combination with carboplatin plus paclitaxel |
| Sub-study 3 Arm C | EXPERIMENTAL | Volrustomig in combination with 5-FU plus platinum |
| Sub-study 4 Arm A | EXPERIMENTAL | Volrustomig in combination with cisplatin + 5-FU |
| Sub-study 4 Arm B | EXPERIMENTAL | Volrustomig in combination with cisplatin + paclitaxel |
| Sub-study 5 | EXPERIMENTAL | Volrustomig monotherapy |
| Cohort 1A | EXPERIMENTAL | Volrustomig monotherapy |
| Cohort 1B | EXPERIMENTAL | Volrustomig combination with bevacizumab |
| Cohort 1C | EXPERIMENTAL | Volrustomig combination with lenvatinib |
| Cohort 2A | EXPERIMENTAL | Rilvegostomig combination with Gemcitabine and Cisplatin |
| Cohort 2B | EXPERIMENTAL | Volrustomig combination with Gemcitabine and Cisplatin |
| Cohort 1D | EXPERIMENTAL | Volrustomig combination with rilvegostomig and bevacizumab |
| Cohort 1E | EXPERIMENTAL | Rilvegostomig combination with bevacizumab |
| Arm 1A (Volrustomig Dose 1 + Casdatifan) | EXPERIMENTAL | Participants will receive dose 1 of volrustomig in combination with casdatifan. |
| Arm 1B (Volrustomig Dose 2 + Casdatifan) | EXPERIMENTAL | Participants will receive dose 2 of volrustomig in combination with casdatifan. |
| MEDI5752 monotherapy | EXPERIMENTAL | - |
| Dose Exploration | EXPERIMENTAL | The Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (\~72 patients) |
| Dose Expansion | EXPERIMENTAL | Evaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (\~105 patients ) |
| Arm A: MEDI5752 | EXPERIMENTAL | MEDI5752 |
| Arm B: MEDI5752 and chemotherapy | EXPERIMENTAL | MEDI5752, pemetrexed, carboplatin and paclitaxel. |
| Arm C: Pembrolizumab and chemotherapy | ACTIVE_COMPARATOR | pembrolizumab, pemetrexed, and carboplatin |
| Name | Type | Description |
|---|---|---|
| volrustomig | DRUG | volrustomig |
| Pemetrexed | DRUG | Alimta: Administered as IV infusion |
| Carboplatin | DRUG | Paraplatin: Administered as IV infusion |
| Cisplatin | DRUG | Platinol: Administered as IV infusion |
| Nivolumab | DRUG | Opdivo: Administered as IV infusion |
| Ipilimumab | DRUG | Yervoy: Administered as IV infusion |
| Pembrolizumab | DRUG | Pembrolizumab |
| Paclitaxel | DRUG | Paclitaxel |
| Placebo | OTHER | IV Infusion |
| FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) | DRUG | FOLFIRI will be administered as IV infusion. |
| Bevacizumab | DRUG | Bevacizumab will be administered as IV infusion. |
| Ramucirumab | DRUG | Participants will receive ramucirumab via IV infusion. |
| 5-FU | DRUG | IV Infusion |
| Lenvatinib | DRUG | Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops. |
| Rilvegostomig | DRUG | anti- PD-1 and TIGIT bispecific antibody |
| Gemcitabine | DRUG | 1000 mg/m2, IV infusion |
| Casdatifan | DRUG | Casdatifan will be administered orally. |
| MEDI5752 | BIOLOGICAL | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. |
| Axitinib | DRUG | INLYTA |
| Paclitaxel or Nab-Paclitaxel | DRUG | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
Inclusion Criteria: * Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0). * Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of th...
MEDI5752 is an investigational monoclonal antibody being studied for the treatment of selected advanced solid tumors, advanced solid tumors, and advanced renal cell carcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MEDI5752 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is in Phase 1 clinical trials for oncology indications.
MEDI5752 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. Clinical trials are ongoing to evaluate its safety and efficacy in patients with advanced solid tumors and advanced renal cell carcinoma.
MEDI5752 is being studied in three Phase 1 clinical trials. NCT03530397 evaluates the drug in subjects with selected advanced solid tumors. NCT04522323 studies MEDI5752 in combination with axitinib in advanced renal cell carcinoma. NCT05685472 was conducted in Japanese patients with advanced solid tumors.
No alternative names for MEDI5752 have been disclosed. The drug is identified solely by its code name MEDI5752 in clinical trial registries and scientific literature.