Trial · NCT04163952

Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin

NCT04163952, Phase 1, Terminated, Rutgers, The State University of New Jersey; results first posted 2024-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin. Trials, record NCT04163952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04163952

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin
NCT number: NCT04163952
Status: Terminated
Phases: Phase 1
Enrollment: 5 participants, actual
Lead sponsor: Rutgers, The State University of New Jersey
Conditions: Locally Advanced Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma
Interventions: Panitumumab, Talimogene Laherparepvec
First posted: 2019-11-15
Last updated: 2026-01-23
Results first posted: 2024-01-18

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0	Up to 30 days	Number of participants who experience adverse effects greater than or equal to a grade three as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Grade 1-4, with 4 being the most severe.
Primary	Response Rate to Panitumumab as Measured by Evaluation of the Criteria in Solid Tumors (RECIST) 1.1.	Up to two years	Response will be evaluated by using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Changes in the largest diameter (unidimensional measurement)of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements.
Secondary	Best Overall Response Rate (ORR) of Participants From Start to Progression of Disease	Up to two years	Best response on treatment was based on RECIST 1.1 criteria. Complete response (CR) is complete disappearance of all targeted lesions. Partial response (PR) is at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference baseline sum. LD Progressive disease (PD) is at least 20% increase in the sum of the longest diameter of the targeted lesions, taking as reference the smallest sum recorded in treatment PD for the evaluation of non-targeted lesions is the appearance of one or more new lesions and or progression of non-targeted lesions. Stable disease is defined as any condition not meet above criteria. The response rate of the drug will be assessed according to the decision rule based on Simons two-stage design.
Secondary	Durable Response Rate Based on Simons Two-stage Design	Up to two years	Will be defined as the percent of participants with complete response or partial response maintained continuously for a minimum of six months. The response rate of the drug will be assessed according to the decision rule based on Simons two-stage design.
Secondary	Duration of Response Based on Simons Two-stage Design	Time from initial response until document progression up to two years	The response rate of the drug will be assessed according to the decision rule based on Simon?s two-stage design.
Secondary	Progression-free Survival (PFS) to Assess Participants Progressive Free-survival	From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to 2 years	The estimate of PFS will be performed by the Kaplan-Meier product limit model.\>valuated by RECIST 1.1.
Secondary	Change in Overall Survival (OS) Measured by the Kaplan-Meier	From date of enrollment to the date of death or date last known alive, whichever comes first, assessed up to assessed up to two years	The estimate of OS will be performed by the Kaplan-Meier product limit model.
Secondary	Mutation Load in Tumor Tissue Measured by Next Generation Sequencing	Up to two years	Next generation sequencing (NGS) is a massively parallel sequencing technology that offers ultra-high throughput, scalability, and speed. The technology is used to determine the order of nucleotides in entire genomes or targeted regions of DNA or RNA, and has the ability to detect variants at lower allele frequencies. With response to therapy and but the actual knowledge of the genetic basis of participants disease.
Secondary	Deoxyribonucleic Acid Mutation Signature in Tumor Tissue	Up to two years	Will be analyzed by next generation sequencing with response to therapy.
Secondary	Messenger Ribonucleic Acid Signature in Tumor Tissue Measured by Nanostring Technology	Up to two years	Nanostring is an amplification-free technology that measures nucleic acid content by counting molecules directly. NanoString provides several pre-made gene expression panels that examine up to 770 genes at once and custom CodeSets for up to 800 targets. With response to therapy and descriptive statistics applied.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0	Up to 30 days	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Response Rate to Panitumumab as Measured by Evaluation of the Criteria in Solid Tumors (RECIST) 1.1.	Up to two years
SECONDARY	Best Overall Response Rate (ORR) of Participants From Start to Progression of Disease	Up to two years
SECONDARY	Durable Response Rate Based on Simons Two-stage Design	Up to two years
SECONDARY	Duration of Response Based on Simons Two-stage Design	Time from initial response until document progression up to two years
SECONDARY	Progression-free Survival (PFS) to Assess Participants Progressive Free-survival	From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to 2 years
SECONDARY	Change in Overall Survival (OS) Measured by the Kaplan-Meier	From date of enrollment to the date of death or date last known alive, whichever comes first, assessed up to assessed up to two years
SECONDARY	Mutation Load in Tumor Tissue Measured by Next Generation Sequencing	Up to two years
SECONDARY	Deoxyribonucleic Acid Mutation Signature in Tumor Tissue	Up to two years
SECONDARY	Messenger Ribonucleic Acid Signature in Tumor Tissue Measured by Nanostring Technology	Up to two years

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0	Treatment (Talimogene Laherparepvec, Panitumumab)		2		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Talimogene Laherparepvec, Panitumumab)	5
Overall Study	COMPLETED	Treatment (Talimogene Laherparepvec, Panitumumab)	5
Overall Study	NOT COMPLETED	Treatment (Talimogene Laherparepvec, Panitumumab)	0

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	3	5	3
other	Nausea	Gastrointestinal disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	3	5	4
other	Abdominal pain	Gastrointestinal disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	2	5	2
other	Constipation	Gastrointestinal disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	2	5	3
other	Gastric hemorrhage	Gastrointestinal disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	1	5	1
other	Upper gastrointestinal hemorrhage	Gastrointestinal disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	1	5	1
other	Fatigue	General disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	4	5	10
other	Fever	General disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	2	5	6
other	Chills	General disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	1	5	1
other	Pain	General disorders	Treatment (Talimogene Laherparepvec, Panitumumab)	1	5	1

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Talimogene Laherparepvec, Panitumumab)	1	5
Total, other adverse events	Treatment (Talimogene Laherparepvec, Panitumumab)	5	5
Total, serious adverse events	Treatment (Talimogene Laherparepvec, Panitumumab)	2	5

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA072720	Cancer Center Support Grant	LIBUTTI, STEVEN K.	RUTGERS BIOMEDICAL AND HEALTH SCIENCES	NATIONAL CANCER INSTITUTE	1997 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04163952

GET https://conductscience.org/api/trials/v1/NCT04163952/events?page=2

API reference For AI assistants