Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V935 · 1 trial · 8 indications
DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
| Arm | Type | Description |
|---|---|---|
| Part A: V935 LD | EXPERIMENTAL | Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period. |
| Part A: V934 LD(3)+V935 LD | EXPERIMENTAL | Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period. |
| Part A: V935 HD | EXPERIMENTAL | Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period. |
| Part A: V934 HD(3)+V935 HD | EXPERIMENTAL | Three EP injections of V934 (HD), 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period. |
| Part A: V934 HD(5)+V935 HD | EXPERIMENTAL | Five EP injections of V934 (HD), 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period. |
| Part B: V935 LD/V934 Booster | EXPERIMENTAL | Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. |
| Part B: V934 LD(3)+V935 LD/V934 Booster | EXPERIMENTAL | Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks. |
| Part B: V935 HD/V934 Booster | EXPERIMENTAL | Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks. |
| Part B: V934 HD(3)+V935 HD/V934 Booster | EXPERIMENTAL | Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks. |
| Part B: V934 HD(5)+V935 HD/V934 Booster | EXPERIMENTAL | Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| V935 | BIOLOGICAL | A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10\^9 vector genomes/mL) or a HD (1 x 10\^11 vector genomes/mL). |
| V934-EP | BIOLOGICAL | A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL). |
Inclusion Criteria Part A * Participant has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Selected Solid Tumors: Stage I to III non-small cell lung carcinoma (NSCLC); Stage III breast cancer; Stage...
V935 is an investigational monoclonal antibody being studied for the treatment of Non-Small Cell Lung Carcinoma. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development.
V935 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The drug is an investigational monoclonal antibody in Phase 1 clinical development for Non-Small Cell Lung Carcinoma.
V935 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug is no longer in active clinical trials.
V935 has been studied in one clinical trial, NCT00753415, titled "A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)." This Phase 1 trial was completed and enrolled 37 participants with various solid tumors, including Non-Small Cell Lung Carcinoma.
V935 is studied in combination with V934 in the clinical trial NCT00753415, which is titled "A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors." The trial enrolled 37 participants with multiple solid tumor types, including Non-Small Cell Lung Carcinoma.