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Monoclonal Antibodies

Interleukin-2 (IL2) for Adenocarcinoma

Phase 1

Waitlist Available

Led By Ben Creelan, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 40 months

Awards & highlights

Study Summary

This trial will study whether giving TILs with nivolumab is safe and whether it has benefits.

Eligible Conditions

Adenocarcinoma
Non-Small Cell Lung Cancer
Squamous Cell Carcinoma
Adenosquamous Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 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

Rate of Dose Limiting Toxicity (DLT)

Secondary outcome measures

Number of Participants With Objective Response

Trial Design

1Treatment groups

Experimental Treatment

Group I: TIL+ NivolumabExperimental Treatment6 Interventions

Tumor-infiltrating Lymphocyte Therapy (TIL) + Nivolumab Treatment Plan: Tumor harvest, Tumor-infiltrating Lymphocytes growth, 4 cycles of nivolumab, cytoreductive chemotherapy with cyclophosphamide and fludarabine, TIL infusion, Interleukin-2 treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Tumor-infiltrating Lymphocytes (TIL)

2017

Completed Phase 1

~20

Nivolumab

2014

Completed Phase 3

~4750

Interleukin-2 (IL2)

2017

Completed Phase 1

~20

Cyclophosphamide

1995

Completed Phase 3

~3780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Industry Sponsor

20 Previous Clinical Trials

1,676 Total Patients Enrolled

Stand Up To CancerOTHER

51 Previous Clinical Trials

40,274 Total Patients Enrolled

12 Trials studying Adenocarcinoma

503 Patients Enrolled for Adenocarcinoma

Prometheus Inc.Industry Sponsor

2 Previous Clinical Trials

131 Total Patients Enrolled

Frequently Asked Questions

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

Do you have any available spots for individuals to participate in the research?

"According to the information on clinicaltrials.gov, enrollment for this research has ended. Initially posted in October 2017 and last revised November 2022, no new participants can join at present; however there are 5900 alternative trials presently recruiting applicants."

Answered by AI

How viable is Tumor-infiltrating Lymphocyte Therapy for patient welfare?

"Our team at Power gave Tumor-infiltrating Lymphocyte Therapy a score of 1, as it is currently in the first phase of clinical trials with limited data to support its safety and efficacy."

Answered by AI

To what illnesses is Tumor-infiltrating Lymphocyte Therapy commonly utilized?

"Tumor-infiltrating Lymphocyte Therapy is often used to treat multiple sclerosis, and can also be employed for the management of leukemia, myelocytic, acute malignant neoplasms and refractory melanoma."

Answered by AI

Has Tumor-infiltrating Lymphocyte Therapy been studied previously?

"Presently, there are 1,604 ongoing studies dedicated to Tumor-infiltrating Lymphocyte Therapy. Of those clinical trials, 243 have progressed to Phase 3. While the majority of these investigations into this particular therapy take place in Philadelphia, Pennsylvania - a total of 68,052 sites are participating in research for it."

Answered by AI

What is the size of the cohort being recruited into this clinical trial?

"Unfortunately, this medical trial is not currently recruiting participants. It was first posted on October 11th 2017 and last modified November 11th 2022. For those looking for alternatives, there are 4296 clinical trials seeking individuals with carcinoma adenosquamous and 1604 studies involving Tumor-infiltrating Lymphocyte Therapy that are actively enrolling patients."

Answered by AI

Recent research and studies

Nature MedicineJournal

Tumor-infiltrating Lymphocyte Treatment for Anti-pd-1-resistant Metastatic Lung Cancer: A Phase 1 Trial

Creelan, Benjamin C., Chao Wang, Jamie K. Teer, Eric M. Toloza, Jiqiang Yao, Sungjune Kim, Ana M. Landin, et al.. 2021. “Tumor-infiltrating Lymphocyte Treatment for Anti-pd-1-resistant Metastatic Lung Cancer: A Phase 1 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01462-y.

clinicaltrials.govStudy

Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer

2017. "Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215810.