Trial of Immunotherapy With Avelumab and Pepinemab As Second Line For Patients With Metastatic Pancreatic Adenocarcinoma

NCT05102721 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SGIP21027
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will assess the safety and tolerability of Pepinemab in combination with Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed after first line chemotherapy. Phase 2 will assess the efficacy of this combination therapy.

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Measured by adverse event severity and quantity

  10 years

Study Arms (1)

Experimental

EXPERIMENTAL

Single arm, all patients serially enrolled to combination doses of Avelumab and Pepinemab

Drug: Avelumab and Pepinemab

Interventions

Avelumab and Pepinemab DRUG

IV Infusions every two weeks.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient or legally acceptable representative must be able to understand and willing to sign an IRB approved written informed consent document.
• Patients must be 18 years or older
• Patients must have histologically confirmed metastatic pancreatic adenocarcinoma.
• Patients must have radiographically measurable disease defined as non-radiated lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 10mm with calipers by radiographic exam.Further details listed in section 5.5.
• Patients must have received 5FU or Gemcitabine based first line treatment (in combination with platinum, topoisomerase I inhibitor, or nab-paclitaxol) for metastatic disease with evidence of treatment failure or intolerance.
• If a subject received therapy in the adjuvant/neoadjuvant setting:
• Tumor recurrence must have occurred no sooner than 6 months after completion of the last dose of therapy.
• Radiation therapy for the locally advanced disease is allowed
• The patient must have a life expectancy of minimum 3 months.
• Patient must have normal bone marrow and organ function as defined below:
• Absolute neutrophil count \>1,500/mcl
• Platelets \>100,000/mcl
• Hemoglobin \>9.0 g/dL
• Creatinine should be below the upper limit of normal OR
• Creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

You may not qualify if:

• Patient with any histologic variant of PDAC such as adenosquamous, acinar cell, duodenal adenocarcinoma, or ampullary adenocarcinoma
• Patient has a history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
• Patient who is receiving or has received an investigational immunotherapy, investigational combinations of cytotoxic chemotherapy such as liposomal irinotecan are permitted
• Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Pepinemab (VX15/2503) or Avelumab
• Patient with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, any clinically active malabsorption syndrome, inflammatory bowel disease, any condition that increases the risk of severe irinotecan gastrointestinal toxicity, or psychiatric illness/social situations that would limit compliance with study requirements
• Has an active autoimmune disease, or a documented history of autoimmune disease or a syndrome that requires steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be exceptions to this rule.
• Has had an allogenic tissue/solid organ transplant.
• Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
• Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Flu vaccines that do not contain live virus are permitted.
• Has known active Hepatitis B or C.
• Patient who is pregnant and/or breastfeeding.
• Persisting toxicity related to prior anti-cancer therapy
• Major surgery or use of investigational drug within the 28 days before the start of treatment
• Current alcohol or drug abuse
• Prior organ or bone marrow transplantation

Sponsors & Collaborators

• Vaccinex Inc.: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

avelumab; pepinemab

Study Officials

• Daniel Mulkerin, MD

  WCICTOResearch@urmc.rochester.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 1, 2021
• Study Start: December 10, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available for 7 years from accrual of the first subject

Locations

US (1)