Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Nivolumab

Immunoglobulins

Antibodies, Blocking

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M

Administer intravenously once every 28-day Cycle

APX005M

Administer intravenously twice every 28-day cycle

Administer intravenously on 3 times every 28-day cycle

Nab-Paclitaxel

Administer intravenously 3 times every 28-day cycle

Parker Institute for Cancer Immunotherapy

The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.

Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

The primary endpoint was the 1-year OS rate of each treatment arm, compared to the historical rate of 35% for gemcitabine and nab-Paclitaxel. OS was defined as the time from treatment initiation until death from any cause. Patients who were not reported as having died at the time of analysis were censored at the most recent contact date. OS and the 1-year OS rate were estimated by the Kaplan-Meier method for each treatment arm. The 1-year OS rate and corresponding one-sided, 95% CI were calculated to determine whether the lower bound of the CI excluded the assumed historical value of 35%. P values were calculated using a one-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%. This study was not powered for statistical comparison between arms.

Phase 1b DLT-Evaluable Population. Overall Response Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1. Overall Response (OR) = CR + PR.

DOR was the time from the first tumor assessment demonstrating response until the date of radiographic disease progression. DOR and the CIs were estimated using the Kaplan-Meier method.

Phase 2 Secondary Efficacy Outcome. Disease Control Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as defined by RECIST v1.1.

PFS is defined as the time from treatment initiation until radiographic disease progression or death (whichever occurred first). PFS and the CIs were estimated using the Kaplan-Meier method.

Phase 2 Secondary Efficacy Outcome. Overall Response Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1. Overall Response (OR) = CR + PR.

Bristol-Myers Squibb

Apexigen America, Inc.

Cancer Research Institute, New York City

Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.

Gemcitabine+Nab-Paclitaxel+nivolumab

Nivolumab: Administer intravenously twice every 28-day cycle

Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle

Gemcitabine: Administer intravenously 3 times every 28-day cycle

Gem/NP/Nivolumab

Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)

APX005M: Administer intravenously once every 28-day Cycle

Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle

Gemcitabine: Administer intravenously 3 times every 28-day cycle

Gem/NP/APX005M (0.1 mg/kg)

Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)

APX005M: Administer intravenously once every 28-day Cycle

Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle

Gemcitabine: Administer intravenously 3 times every 28-day cycle

Gem/NP/APX005M (0.3 mg/kg)

Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)

APX005M: Administer intravenously once every 28-day Cycle

Nivolumab: Administer intravenously twice every 28-day cycle

Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle

Gemcitabine: Administer intravenously 3 times every 28-day cycle

Gem/NP/Nivolumab/APX005M (0.1 mg/kg)

Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)

APX005M: Administer intravenously once every 28-day Cycle

Nivolumab: Administer intravenously twice every 28-day cycle

Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle

Gemcitabine: Administer intravenously 3 times every 28-day cycle

Gem/NP/Nivolumab/APX005M (0.3 mg/kg)

Phase 1b: Gem/NP/APX005M (0.1 mg/kg)

Phase 1b: Gem/NP/APX005M (0.3 mg/kg)

Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)

Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)

Phase 2: Gem/NP/Nivolumab

Phase 2: Gem/NP/APX005M (0.3 mg/kg)

Phase 2: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

The Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status is one such measurement. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The ECOG Performance Status ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).

ECOG Performance Score

Cancer Location

Prior Chemotherapy

Prior Cancer Surgery

Prior Radiation

Prior Treatment

Cancer Stage at Initial Diagnosis

The Phase 1b Safety Population is defined as all patients who were enrolled in Phase 1b and who received at least 1 dose of any study drug. The Phase 2 Efficacy Population is defined as all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug.

Ute Dugan

Adverse Events (AEs)

Serious Adverse Events (SAEs)

Dose-Limiting Toxicities (DLTs)

The DLT-Evaluable Population is defined as all Phase 1b patients who received at least 2 doses of NP, at least 2 doses of Gem, and 1 dose of APX005M during Cycle 1.

Phase 1b Primary Safety Outcome

Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.

The Efficacy Population is defined as (1) all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and (2) the 12 DLT-evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose.

1-year Overall Survival Rate

Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M

APX005M: Administer intravenously once every 28-day Cycle

Nivolumab: Administer intravenously twice every 28-day cycle

Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle

Gemcitabine: Administer intravenously 3 times every 28-day cycle

Objective Response Rate (ORR): DLT-Evaluable Population

Patients in the DLT-Evaluable Population (defined as all Phase 1b patients who received at least 2 doses of NP, at least 2 doses of Gem, and 1 dose of APX005M during Cycle 1) and who achieved a Partial Response or Complete Response.

Duration of Response (DOR): DLT-Evaluable Population

Disease Control Rate (DCR)

Progression-free Survival (PFS)

The Efficacy Population is defined as (1) all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and (2) the 12 DLT-evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose (Arms B2 and C2).

Objective Response Rate (ORR): Efficacy Population

Patients in the Efficacy Population (defined as all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and the 12 DLT-Evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose) and who achieved a Partial Response or Complete Response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma	NCT03214250	Metastatic Panc...	APX005M Nivolumab Nab-Paclitaxel Gemcitabine	18 Years -	Parker Institute for Cancer Immunotherapy
Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma	NCT03214250	Metastatic Panc...	APX005M Nivolumab Nab-Paclitaxel Gemcitabine	18 Years -	Parker Institute for Cancer Immunotherapy

Spots Global Cancer Trial Database for previously untreated metastatic pancreatic adenocarcinoma