Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma

Part of paid clinical trials in New York, New York.

Sponsor
Gulam Manji
Study ID
NCT04543071
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motixafortide — DRUG
    1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
  • Cemiplimab — DRUG
    350 mg intravenous (IV) once every 21 days
  • Gemcitabine — DRUG
    1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
  • Nab paclitaxel — DRUG
    125 mg/m2 IV on days 1, 8, 14 (every 28 days)

Study Details

The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.

Key Dates

Start date
Nov 9, 2020
Status verified
Jun 2025
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
    Participants will receive standard FDA-approved doses of gemcitabine and nab-paclitaxel for pancreas cancer and cemiplimab at the dose that is approved for participants with skin cancer. Participants will also receive motixafortide at a dose that has been deemed safe in previous studies when used in combination with immunotherapy and chemotherapy. If the combination study treatment causes a serious side effect in participants, the study treatment will be modified.

Primary Outcome Measure

Overall Response Rate (Complete Response (CR) + Partial Response (PR)) [ Time Frame: 16 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Gulam Manji, MD, PhD (PRINCIPAL_INVESTIGATOR)
Brown UniversityProvidenceRhode Island02912
Alexander Raufi, MD
[email protected]
18442222881
Alexander Raufi, MD (PRINCIPAL_INVESTIGATOR)
Medical College of Wisconsin, Wisconsin Diagnostic LabratoriesMilwaukeeWisconsin53226
Mandana Kamgar, MD
[email protected]
414-805-0505

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