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Immune Cell Growth Factor

Combination Immunotherapy + Radiation for Cancer

Phase 1 & 2
Recruiting
Led By Joshua Brody, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have pathologically confirmed iNHL, MBC or HNSCC
Lymphoma subtypes that may be enrolled include small lymphocytic lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a combination of 4 therapies to see if they are more effective than each therapy alone. 3 of the therapies are used to treat a single "target site" of your cancer, and the 4th is given directly into the blood stream.

Who is the study for?
This trial is for adults with certain cancers like lymphoma, breast cancer, and head & neck cancer. It's not for those who've had recent cancer treatment or have active infections, autoimmune diseases needing treatment in the past year, known psychiatric/substance abuse issues that could affect participation, are pregnant/breastfeeding, or have untreated brain metastases.Check my eligibility
What is being tested?
The trial tests a combo of low-dose radiation to shrink tumors and three drugs: Flt3L to boost immune cells; Poly-ICLC to activate them; Pembrolizumab (an FDA-approved antibody) via IV to help the immune system fight the tumor. The goal is seeing if this mix can better target and kill cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, flu-like symptoms from immune activation (fever, fatigue), potential worsening of autoimmune conditions due to pembrolizumab's effect on the immune system. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is either iNHL, MBC, or HNSCC.
Select...
My lymphoma type is small lymphocytic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Overall response rate (ORR)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination therapyExperimental Treatment4 Interventions
Vaccination with Flt3L, Radiation, and Poly ICLC combined with Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly ICLC
2014
Completed Phase 2
~270
Pembrolizumab
FDA approved
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,797 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
854 Previous Clinical Trials
535,934 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,814 Total Patients Enrolled

Media Library

Flt3L (Immune Cell Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT03789097 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Combination therapy
Non-Hodgkin's Lymphoma Clinical Trial 2023: Flt3L Highlights & Side Effects. Trial Name: NCT03789097 — Phase 1 & 2
Flt3L (Immune Cell Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03789097 — Phase 1 & 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 are being admitted to this clinical trial?

"Indeed, the clinicaltrials.gov website verifies that recruitment for this medical research is ongoing; its listing was first created on April 5th 2019 and most recently updated on October 18 2021. This investigation necessitates 56 participants from a single site."

Answered by AI

What therapeutic applications is Pembrolizumab most widely administered for?

"Pembrolizumab is primarily used to treat cancerous neoplasms, though it has been known to help those with melanoma that cannot be surgically resected, microsatellite instability high cases, and individuals whose disease progressed past chemotherapy."

Answered by AI

Are there any enrollment opportunities available for this experiment?

"Data on clinicaltrials.gov asserts that this medical trial is actively enlisting participants, with the initial post being dated April 5th 2019 and most recently modified October 18th 2021."

Answered by AI

What previous experiments have been done to assess the effectiveness of Pembrolizumab?

"Presently, there are 961 clinical trials for Pembrolizumab; of which 122 have entered Phase 3. Most studies related to this drug occur in Houston, Texas though it is being tested at 35731 trial locations worldwide."

Answered by AI
~9 spots leftby Mar 2025