Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cabiralizumab · 2 trials · 2 indications
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) |
| Arm B | EXPERIMENTAL | Cabiralizumab Q2W + Nivolumab Q4W |
| Arm C | EXPERIMENTAL | Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W |
| Arm D | EXPERIMENTAL | Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W |
| Monotherapy | EXPERIMENTAL | Cabiralizumab administered as a single agent intravenous formulation |
| Combination Therapy | EXPERIMENTAL | Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation |
| Name | Type | Description |
|---|---|---|
| Cabiralizumab | BIOLOGICAL | specified dose on specified days |
| Nab-paclitaxel | DRUG | specified does on specified days |
| Onivyde | DRUG | specified dose on specified days |
| Nivolumab | BIOLOGICAL | specified dose on specified days |
| Fluorouracil | DRUG | specified dose on specified days |
| Gemcitabine | DRUG | specified dose on specified days |
| Oxaliplatin | DRUG | specified dose on specified day |
| Leucovorin | DRUG | Specified dose on specified days |
| Irinotecan Hydrochloride | DRUG | Specified dose on specified days |
Inclusion Criteria: * Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy * ECOG Performance status 0-1 * Adequate organ functions * Measurable disease Exclusion Criter...
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Cabiralizumab is an investigational monoclonal antibody being studied for advanced pancreatic cancer and advanced malignancies. It has been evaluated in clinical trials for these oncology indications, including a Phase 2 study in advanced pancreatic cancer and a Phase 1 study in advanced malignancies.
Cabiralizumab is a monoclonal antibody, classified as a -mab (antibody) therapeutic. It is being developed by Bristol-Myers Squibb for use in oncology, specifically in combination with other treatments for advanced cancers.
Cabiralizumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has sponsored clinical trials evaluating the drug in advanced pancreatic cancer and advanced malignancies.
Cabiralizumab has completed clinical trials, including a Phase 1 study and a Phase 2 study. The Phase 2 trial evaluated the drug in advanced pancreatic cancer, while the Phase 1 trial assessed it in advanced malignancies. The drug remains investigational.
Cabiralizumab has been studied in two completed trials. NCT03158272 was a Phase 1 study of cabiralizumab alone or with nivolumab in advanced malignancies, enrolling 19 patients in Japan. NCT03336216 was a Phase 2 study with nivolumab, with and without chemotherapy, in advanced pancreatic cancer, enrolling 205 patients across multiple countries.
Cabiralizumab is a distinct investigational monoclonal antibody. It has been studied in combination with nivolumab in clinical trials for advanced cancers, but it is not the same drug as nivolumab.