NCT03521570 is a Phase 2 clinical trial of IMRT in Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Emory University.

Who is sponsoring NCT03521570?

NCT03521570 is sponsored by Emory University.

What drugs are being tested in NCT03521570?

Interventions in NCT03521570: IMRT, Nivolumab.

What condition does NCT03521570 study?

NCT03521570 studies Recurrent Head and Neck Squamous Cell Carcinoma.

Is NCT03521570 still recruiting?

NCT03521570 is currently completed. Last updated 19 September 2024.

Are results published for NCT03521570?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-19 · How we verify

NCT03521570

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

Completed Phase 2 Results posted Last updated 19 September 2024

What this trial tests

Phase 2 trial testing IMRT in Recurrent Head and Neck Squamous Cell Carcinoma in 62 participants. Completed in 7 September 2023.

Timeline

28 June 2018

Primary endpoint
25 July 2022

7 September 2023

Quick facts

Lead sponsor	Emory University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	28 June 2018
Primary completion	25 July 2022
Estimated completion	7 September 2023
Sites	4 locations across United States

Drugs / interventions tested

IMRT
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Recurrent Head and Neck Squamous Cell Carcinoma — all drugs for Recurrent Head and Neck Squamous Cell Carcinoma →

Sponsor

Emory University

Who can join

18 and older, any sex, with Recurrent Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Progression-Free Survival (PFS) Primary · 1 year from study start

95% confidence interval will be estimated by Kaplan-Meier method for all participants.

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	27

Number of Participants With Overall Survival (OS) Secondary · 1 year from study start

Will be assessed using Kaplan-Meier method.

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	84.4	74.4 – 95.7

Number of Participants With Pattern of Failure Secondary · 1 year from study start

To evaluate patterns of failure as local, regional, or distant.

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	2

Number of Participants With Incidence of Acute Adverse Events Secondary · Up to 1 year from study start

Acute toxicities will be identified and their incidence rate estimated.

fatigue

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	82.4

dermatitis

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	58.8

dysphagia

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	54.9

mucositis

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	49

dry mouth

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	47.1

Lymphopenia

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	11.8

Number of Participants With Incidence of Late Adverse Events Secondary · 2 years from study start

Late toxicities will be identified and their incidence rate estimated.

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	3

Quality of Life (QOL) Secondary · At baseline, end of Intensity-Modulated Radiation Therapy, and weeks 18, 30, 52, and 104, baseline and month 12

The FACT-HN (Functional Assessment of Cancer Therapy-Head and Neck) (version 4) consists of a cancer-specific questionnaire, FACT-G (Functional Assessment of Cancer Therapy - General), in addition to 12 H\&N cancer-specific items (the HN subscale).The Functional Assessment of Cancer Therapy-Head and Neck Quality of Life questionnaire may be completed by the patient using paper or electronically. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL

Baseline

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	68	± 89.2

End of IMRT

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	62.5	± 90

Week 18

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	62	± 93.4

Week 30

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	74.6	± 101

Week 52

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	59	± 94.5

Week 104

Group	Value	95% CI
Treatment (Nivolumab, IMRT)	59	± 94.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Nivolumab, IMRT)

Serious: 24/51 (47%)

Deaths: 24/51

Serious adverse events (1 terms)

Reaction	System	Treatment (Nivolumab, IMRT)
Death	General disorders	—

Other adverse events (180 terms — click to expand)

Reaction	System	Treatment (Nivolumab, IMRT)
Fatigue	General disorders	—
Dermatitis radiation	Injury, poisoning and procedural complications	—
Dysphagia	Gastrointestinal disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Dysgeusia	Nervous system disorders	—
Anorexia	Metabolism and nutrition disorders	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Hypothyroidism	Endocrine disorders	—
Anemia	Blood and lymphatic system disorders	—
Oral pain	Gastrointestinal disorders	—
Anxiety	Psychiatric disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—
Weight loss	Investigations	—
Lymphocyte count decreased	Investigations	—
Pain	General disorders	—
Infections and infestations - Other, specify	Infections and infestations	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Depression	Psychiatric disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Diarrhea	Gastrointestinal disorders	—
General disorders and administration site conditions - Other, specify	General disorders	—
Dizziness	Nervous system disorders	—
Insomnia	Psychiatric disorders	—
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—
Trismus	Musculoskeletal and connective tissue disorders	—
Paresthesia	Nervous system disorders	—
Headache	Nervous system disorders	—
Neck pain	Musculoskeletal and connective tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Aspartate aminotransferase increased	Investigations	—
Respiratory, thoracic and mediastinal disorders - Other, specify	Respiratory, thoracic and mediastinal disorders	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—
Creatinine increased	Investigations	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03521570 adverse events section.

Sponsor's own description

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007
Combining Radiation and Immune Checkpoint Blockade in the Treatment of Head and Neck Squamous Cell Carcinoma.
Manukian G, Bar-Ad V, Lu B, Argiris A, et al · · 2019 · cited 57× · PMID 30895168 · DOI 10.3389/fonc.2019.00122
Radiotherapy and Immunotherapy for Head and Neck Cancer: Current Evidence and Challenges.
Qian JM, Schoenfeld JD. · · 2020 · cited 47× · PMID 33614492 · DOI 10.3389/fonc.2020.608772
Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
Immunotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Hsieh RW, Borson S, Tsagianni A, Zandberg DP. · · 2021 · cited 27× · PMID 34540672 · DOI 10.3389/fonc.2021.705614
Challenges in Combining Immunotherapy with Radiotherapy in Recurrent/Metastatic Head and Neck Cancer.
Plavc G, Jesenko T, Oražem M, Strojan P. · · 2020 · cited 19× · PMID 33143094 · DOI 10.3390/cancers12113197
Radiotherapy as a New Player in Immuno-Oncology.
Wang SJ, Haffty B. · · 2018 · cited 19× · PMID 30558196 · DOI 10.3390/cancers10120515
Intensity-Modulated Reirradiation Therapy With Nivolumab in Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma: A Nonrandomized Controlled Trial.
Saba NF, Wong SJ, Nasti T, McCook-Veal AA, et al · · 2024 · cited 13× · PMID 38780927 · DOI 10.1001/jamaoncol.2024.1143

Verify or expand the search:

Other trials of IMRT

Trials testing the same drug.

NCT06764680 — Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanc · Phase 2 · recruiting
NCT06323239 — SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma · Phase 2 · recruiting
NCT06364826 — Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma · Phase 2 · not yet recruiting
NCT06080503 — Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy · NA · recruiting
NCT06314334 — Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma · Phase 2 · recruiting

Other recruiting trials for Recurrent Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT06868433 — TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous · Phase 1 · recruiting
NCT06589804 — Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spre · Phase 3 · recruiting
NCT06662058 — Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radi · NA · recruiting
NCT06678724 — Establishment of a Microfluidic Based Liquid Biopsy Platform for Recurrent/Metastatic Head and Neck Cancers Prognosticat · recruiting

Other Emory University trials

Trials by the same sponsor.

NCT06143345 — HIIT in Isolated IFG: A Proof-of-Concept Study · NA · withdrawn
NCT07189819 — Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait · NA · not yet recruiting
NCT06451055 — Low-calorie Diet in Isolated Impaired Fasting Glucose · NA · not yet recruiting
NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I · Phase 2 · recruiting
NCT06708351 — Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03521570 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03521570.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing