Evidence map›Paper›PMID 34626024›Full record

Trial reportHead & neck2021

Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma.

David M Cognetti, Jennifer M Johnson, Joseph M Curry, Samith T Kochuparambil, Darren McDonald, Frank Mott, Mary J Fidler, Kerstin Stenson, Nilesh R Vasan, Mohammad A Razaq and 7 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Head & neck, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02422979 (A Phase 1/2a Multicenter, Open-Label, Dose-Escalation, Combination Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer, Who in the Opinion of Their Physician, Cannot Be Satisfactorily Treated With Surgery, Radiation or Platinum Chemotherapy), which is not on this map. Cited by 123 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 1 pooled it
15.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02422979 phase1 / phase2completednot on this map

A Phase 1/2a Multicenter, Open-Label, Dose-Escalation, Combination Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer, Who in the Opinion of Their Physician, Cannot Be Satisfactorily Treated With Surgery, Radiation or Platinum Chemotherapy

TypeinterventionalSponsorRakuten Medical, Inc.Ran2015 to 2019Enrolled40ConditionsRecurrent Head and Neck CancerArmsPIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2, PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2, PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2, PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2, PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 1 synthesis or guideline pooled it, 161 citations in OpenAlex.

  1. Pooled it
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  4. Cancer theranostics.Nature reviews. Cancer · 2026
    Review
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  10. Internalization-Dependent EGFR-Targeted Photoactivation by Cetuximab-I21 Conjugates.Journal of immunotherapy (Hagerstown, Md. : 1997) · 2026
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63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 2 countries.

David M CognettiDepartment of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.ORCID 0000-0001-7039-3055
Jennifer M JohnsonSidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Joseph M CurryDepartment of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Samith T KochuparambilDepartment of Medical Oncology, Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA.
Darren McDonaldDepartment of Otolaryngology-Head and Neck Surgery, Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA.
Frank MottDepartment of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Mary J FidlerDepartment of Hematology, Oncology, and Cell Therapy, Rush University Medical Center, Chicago, Illinois, USA.
Kerstin StensonDepartment of Otorhinolaryngology, Rush University Medical Center, Chicago, Illinois, USA.
Nilesh R VasanDepartment of Otolaryngology-Head and Neck Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Mohammad A RazaqDivision of Hematology and Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
John CampanaDepartment of Otolaryngology, University of Colorado Head and Neck Specialists, Denver, Colorado, USA.
Patrick HaDivision of Head and Neck Surgical Oncology, University of California San Francisco, San Francisco, California, USA.
Grace MannDepartment of Clinical Development, Rakuten Medical, Inc, San Mateo, California, USA.
Kosuke IshidaDepartment of Biostatistics, Rakuten Medical Japan, Tokyo, Japan.
Miguel Garcia-GuzmanDepartment of Translational Sciences, Rakuten Medical, Inc, San Diego, California, USA.
Merrill BielDepartment of Clinical Development, Rakuten Medical, Inc, San Mateo, California, USA.
Ann M GillenwaterDepartment of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Thomas Jefferson University · USRush University Medical Center · USSan Mateo Medical Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Oklahoma Health Sciences Center · USDermatology Specialists · USMinnesota Oncology · USRakuten (Japan) · JPRakuten (United States) · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecurrent head and neck squamous cell carcinoma (rHNSCC) represents a significant global health burden with an unmet medical need. In this study we determined the safety and efficacy of RM-1929 photoimmunotherapy in patients with heavily pretreated rHNSCC.

methodsRM-1929 (anti-EGFR-IR700 dye conjugate) was infused, followed by tumor illumination. We evaluated safety, tumor response, and pharmacokinetics.

resultsNine patients were enrolled in Part 1 (dose-finding) and 30 patients in Part 2 (safety and efficacy). No dose-limiting toxicities were experienced in Part 1; 640 mg/m

conclusionsTreatment was well tolerated. Responses and survival following RM-1929 photoimmunotherapy in heavily pretreated patients with rHNSCC were clinically meaningful and warrant further investigation. CLINICAL TRIAL INFORMATION: NCT02422979.

Indexed as

Head and Neck NeoplasmsImmunotherapyNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckAntineoplastic Combined Chemotherapy ProtocolsCetuximabHumansPhototherapyCetuximabcetuximab-IR700 conjugatelight-activatable dye (IRDye 700DX)recurrent head and neck squamous cell carcinoma (rHNSCC)RM-1929 photoimmunotherapytumor-targeted monoclonal antibody

Identifiers

PMID34626024
PMCPMC9293150
OpenAlexW3203960170

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.