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Immunotherapy

anti-PD-1 therapy for Head and Neck Cancers

Phase 2

Waitlist Available

Led By Adam Burr, MD, PhD

Research Sponsored by University of Wisconsin, Madison

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 5 years

Awards & highlights

Study Summary

This trial will evaluate if a combination of anti-PD1, NKTR-214, and palliative radiation therapy is safe and helpful in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Eligible Conditions

Head and Neck Cancer

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Duration of Response

Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores

Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores

+7 more

Other outcome measures

Diversity and Clonality of the T Cell Receptor Repertoire by Deep Sequencing of PBMC

Expression of PD-L1 by Histology

Levels of IFN-γ Expressing and CD122+ T Cells in Peripheral Blood Mononuclear Cells (PBMC)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: NKTR-214, anti-PD therapy plus Palliative RadiationExperimental Treatment3 Interventions

Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2. In subsequent cycles participants will receive NKTR-214 and anti-PD-1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NKTR-214

2018

Completed Phase 3

~820

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,180 Previous Clinical Trials

3,592,345 Total Patients Enrolled

Nektar TherapeuticsIndustry Sponsor

58 Previous Clinical Trials

10,337 Total Patients Enrolled

Adam Burr, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

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

To what extent is enrollment in this trial capped?

"This trial is no longer accepting patients; the original posting was on August 5th 2021 and it has not been updated since May 9th 2022. Alternatively, one can search for other clinical trials that are still recruiting: presently there are 1005 studies exploring oral squamous cell carcinoma treatment options and 967 anti-PD-1 therapy trials admitting participants."

Answered by AI

Has the FDA sanctioned anti-PD-1 therapy?

"The safety of anti-PD-1 therapy was assessed to be a 2, as the Phase 2 trial only has evidence for its security but not efficacy."

Answered by AI

What maladies is anti-PD-1 therapy traditionally employed to treat?

"Anti-PD-1 therapy is commonly prescribed to manage malignant neoplasms. Additionally, this treatment can also help with unresectable melanoma, microsatellite instability high diseases and cases where chemotherapy has failed to produce significant results."

Answered by AI

What other experiments involving anti-PD-1 therapy have been conducted thus far?

"Anti-PD-1 therapy has an extensive number of clinical trials, with 967 presently being conducted and 124 in the third phase. The focus is on Houston, Texas but there are 36430 sites running these studies globally."

Answered by AI

Are new participants invited to join this clinical experiment?

"This clinical trial has ceased recruitment of candidates. It was first listed on August 5th 2021 and last modified on May 9th 2022. If you are seeking a different study, there are presently 1,005 trials enrolling patients with oral squamous cell carcinoma and 967 trials recruiting participants for anti-PD-1 therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma

2021. "Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04936841.