What side effects are associated with this type of intervention?

The combination treatment for adenocarcinoma involving cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is associated with several known side effects. Cemiplimab can cause immune-related reactions such as skin rash and fatigue. Motixafortide is generally safe but lacks detailed side effect data. Gemcitabine commonly leads to neutropenia, fatigue, and gastrointestinal issues. Nab-paclitaxel frequently results in neutropenia, fatigue, and neuropathy. Combining these treatments may amplify these side effects, necessitating careful monitoring.

What prior FDA approvals exist?

For the treatment of pancreatic adenocarcinoma, gemcitabine and nab-paclitaxel are FDA-approved chemotherapy agents. Gemcitabine, often used in combination with nab-paclitaxel, has shown significant efficacy in improving survival rates. Cemiplimab, an immune checkpoint inhibitor, is FDA-approved for skin cancer but not specifically for pancreatic cancer. Motixafortide, an investigational drug, has demonstrated potential in enhancing the effectiveness of immunotherapy but is not yet FDA-approved.

What other types of research exist?

Promising novel alternatives for adenocarcinoma patients considering treatment in 2024 include: 1) Pembrolizumab combined with chemotherapy, which has shown efficacy in various solid tumors and is being explored for its potential in less immunogenic tumors. 2) Nivolumab, an anti-PD-1 antibody, which has shown promising activity in various cancers and is being tested in combination with other agents. 3) Tremelimumab, a CTLA-4 inhibitor, which has shown potential in combination with other immunotherapies. 4) Margetuximab combined with pembrolizumab, which has demonstrated synergistic antitumor activity in HER2-positive gastro-oesophageal adenocarcinoma and may be explored for other adenocarcinomas.

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PD-1 Inhibitor

Combination Therapy for Pancreatic Cancer

Phase 2

Recruiting

Led By Gulam Manji, MD,PhD

Research Sponsored by Gulam Manji

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.

Patients with endocrine or acinar pancreatic carcinoma not eligible

Must not have

Prior surgery for PDAC

Left ventricular ejection fraction below institutional lower limit of normal or below 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of standard chemotherapy, an immune-boosting drug, and a new drug to treat aggressive pancreatic cancer. The goal is to see if this mix can shrink tumors and help patients live longer. The treatment aims to kill cancer cells directly and enhance the body's immune response against the cancer. Gemcitabine is currently the standard treatment for advanced pancreatic cancer.

Who is the study for?

Adults over 18 with stage IV pancreatic adenocarcinoma, not endocrine or acinar types, who haven't had recent major surgery or cancer treatments. They must have a good performance status and organ function, no severe allergies to study drugs, and agree to use birth control if applicable.

What is being tested?

The trial tests a combination of chemotherapy (gemcitabine and nab-paclitaxel), immunotherapy (cemiplimab), and a chemokine inhibitor (motixafortide) for effectiveness in shrinking tumors, extending life, and safety in metastatic pancreatic cancer patients.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation in organs, infusion-related reactions from the drug entering the body, fatigue, blood disorders like low counts of different cell types which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is not endocrine or acinar pancreatic carcinoma.

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I do not have endocrine or acinar pancreatic cancer.

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I have been tested for blood clots and am receiving treatment if any were found.

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My pancreatic cancer diagnosis has been confirmed by a biopsy.

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I am fully active or can carry out light work.

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My cancer is confirmed as metastatic pancreatic adenocarcinoma.

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My stage IV cancer is confirmed by a biopsy and cannot be surgically removed.

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My pancreatic cancer diagnosis has been confirmed by a pathologist.

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I am 18 years old or older.

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My white blood cell count is healthy without needing medication.

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My biopsy confirms I have stage IV cancer that cannot be surgically removed.

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I am fully active or can carry out light work.

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My kidney function, measured by creatinine levels or CrCl, is within the normal range.

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My cancer can be measured and biopsied.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for pancreatic cancer.

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My heart's pumping ability is below normal or less than 50%.

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I have been hospitalized for severe depression or attempted suicide in the last two years.

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I do not have uncontrolled skin, muscle, nerve disorders or a rare blood disorder.

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I haven't had major surgery or significant injury in the last 2 weeks.

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I haven't had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after my treatment.

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I have had a stem cell or organ transplant before.

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I had radiation therapy for pancreatic cancer less than 2 weeks ago.

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I have had cancer spread to my brain or its coverings.

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I have high calcium levels that aren't managed without ongoing treatment.

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I have or had hepatitis B.

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I have a significant liver condition.

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I have active tuberculosis.

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I have not had severe bleeding in the last 28 days.

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I have had treatment for pancreatic cancer before.

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I have not received any blood transfusions in the last 4 weeks.

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I have cancer pain not controlled without changing pain meds in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (Complete Response (CR) + Partial Response (PR))

Secondary study objectives

Disease Control Rate

Duration of Clinical Benefit

Incidence of Treatment Related Toxicities

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Motixafortide, Cemiplimab, Gemcitabine, Nab-PaclitaxelExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

Gemcitabine

2017

Completed Phase 3

~1920

Nab paclitaxel

2014

Completed Phase 2

~580

0 / 31Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for adenocarcinoma include cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel. Cemiplimab activates the immune system to attack cancer cells by blocking the PD-1 pathway. Motixafortide enhances immunotherapy by mobilizing immune cells to the tumor site. Gemcitabine interferes with DNA replication, causing cell death in rapidly dividing cancer cells. Nab-paclitaxel stabilizes microtubules, inhibiting cell division. These treatments are important for adenocarcinoma patients as they target cancer through multiple pathways, potentially improving outcomes and prolonging survival.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.

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Who is running the clinical trial?

Gulam ManjiLead Sponsor

4 Previous Clinical Trials

153 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

671 Previous Clinical Trials

385,814 Total Patients Enrolled

BioLine RxUNKNOWN

Gulam Manji, MD,PhD3.33 ReviewsPrincipal Investigator - Columbia University

Columbia University

4Patient Review

Dr Manji is a great oncologist, but can be forgetful when it comes to scheduling and other responsibilities. I would still recommend him, as long as you are willing to be proactive.