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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
Histological or pathological confirmation of metastatic pancreas adenocarcinoma
Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial diagnostic biopsy or from the required pre-treatment biopsy, prior to initiation of any study-related therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new combination of chemotherapy drugs and immunotherapy to see if it's effective in treating 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.Check my eligibility
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.See study design
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 confirmed as metastatic pancreatic adenocarcinoma.
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My pancreatic cancer diagnosis has been confirmed by a biopsy.
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My stage IV cancer is confirmed by a biopsy and cannot be surgically removed.
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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 am fully active or can carry out light work.
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I have been tested for blood clots and am receiving treatment if any were found.
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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 cancer is confirmed as metastatic pancreatic adenocarcinoma.
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My pancreatic cancer diagnosis has been confirmed by a pathologist.
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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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I am 18 years old or older.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Secondary outcome measures
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
~1340
Gemcitabine
2017
Completed Phase 3
~2070
Nab paclitaxel
2014
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Gulam ManjiLead Sponsor
4 Previous Clinical Trials
153 Total Patients Enrolled
3 Trials studying Adenocarcinoma
110 Patients Enrolled for Adenocarcinoma
Regeneron PharmaceuticalsIndustry Sponsor
607 Previous Clinical Trials
378,372 Total Patients Enrolled
1 Trials studying Adenocarcinoma
98 Patients Enrolled for Adenocarcinoma
BioLine RxUNKNOWN

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04543071 — Phase 2
Adenocarcinoma Research Study Groups: Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
Adenocarcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04543071 — Phase 2
Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04543071 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this study seeking to recruit?

"Affirmative. The information on clinicaltrials.gov elucidates that this investigation is currently soliciting participants. This research effort, which was initially published on November 9th 2020, needs 10 patients from 2 different medical centres to complete the trial."

Answered by AI

Has Motixafortide been evaluated in other investigations?

"Currently, there are 1169 investigations into Motixafortide which have been initiated. Of these ongoing trials, 325 reside in their third and final phase of development. Although the majority of research is based out of Shanghai, 61006 sites support studies for this medication worldwide."

Answered by AI

What medicinal applications is Motixafortide employed for?

"Motixafortide can be employed to treat those with a previous history of anthracycline-based therapies, metastatic cutaneous squamous cell carcinoma, and cancerous metastases."

Answered by AI

Could you please elucidate the risks of Motixafortide usage?

"Our team at Power assigned Motixafortide a rating of 2 as it is currently in Phase 2 clinical trials, with some safety data gathered but none indicating its efficacy."

Answered by AI

Are volunteers being enlisted for this experiment?

"Yes, the information available on clinicaltrials.gov reveals that this research effort is in search of participants. The trial was first made visible to the public on November 9th 2020 and has since been updated as recently as November 7th 2022; it requires 10 volunteers from 2 different medical centres."

Answered by AI
~3 spots leftby Jul 2025