Trial Outcomes & Findings for Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin (NCT NCT04163952)

Last Updated: 2026-01-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2026-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Talimogene Laherparepvec, Panitumumab) Participants receive Talimogene Laherparepvec IM on day one. Participants then receive Talimogene Laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every two weeks for up to three cycles in the absence of disease progression or unacceptable toxicity. Participants may receive up to three additional cycles of treatment per physician discretion. Panitumumab: Given IV Talimogene Laherparepvec: Given IM
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Talimogene Laherparepvec, Panitumumab) n=5 Participants Participants receive Talimogene Laherparepvec IM on day one. Participants then receive Talimogene Laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every two weeks for up to three cycles in the absence of disease progression or unacceptable toxicity. Participants may receive up to three additional cycles of treatment per physician discretion. Panitumumab: Given IV Talimogene Laherparepvec: Given IM
Age, Categorical <=18 years	0 Participants n=270 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=270 Participants
Age, Categorical >=65 years	3 Participants n=270 Participants
Sex: Female, Male Female	2 Participants n=270 Participants
Sex: Female, Male Male	3 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=270 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	1 Participants n=270 Participants
Race (NIH/OMB) White	3 Participants n=270 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec, Panitumumab) n=5 Participants Participants receive Talimogene Laherparepvec IM on day one. Participants then receive Talimogene Laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every two weeks for up to three cycles in the absence of disease progression or unacceptable toxicity. Participants may receive up to three additional cycles of treatment per physician discretion. Panitumumab: Given IV Talimogene Laherparepvec: Given IM
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Will be analyzed by next generation sequencing with response to therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Will be analyzed by flow cytometry with response to therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Cytometry, in its purest form, is the measurement of cell characteristics. Flow cytometry can identify the type of cells in a blood or bone marrow sample, including the types of cancer cells. It detects types of cancer cells based on either the presence or the absence of certain protein markers (antigens) on a cell's surface. This technique allows researchers to get highly specific information about individual cells. Flow cytometry will be used, with response to therapy and descriptive statistics applied.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Will be analyzed by flow cytometry, any suspended particle or cell from 0.2-150 micrometers in size, is suitable for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Will be analyzed by flow cytometry, any suspended particle or cell from 0.2-150 micrometers in size is suitable for analysis, with response to therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Pathologic complete response (pCR) was defined as percent necrosis of the surgical specimen greater than or equal to 90% .Pathologic complete response (pCR) is a surrogate endpoint to demonstrate the study drug's efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

A resectable tumor is one in which there is no technical barrier to surgical excision. Able to be removed by surgery.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Talimogene Laherparepvec, Panitumumab)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Talimogene Laherparepvec, Panitumumab) n=5 participants at risk Participants receive Talimogene Laherparepvec IM on day one. Participants then receive Talimogene Laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every two weeks for up to three cycles in the absence of disease progression or unacceptable toxicity. Participants may receive up to three additional cycles of treatment per physician discretion. Panitumumab: Given IV Talimogene Laherparepvec: Given IM
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.

Other adverse events

Other adverse events
Measure	Treatment (Talimogene Laherparepvec, Panitumumab) n=5 participants at risk Participants receive Talimogene Laherparepvec IM on day one. Participants then receive Talimogene Laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every two weeks for up to three cycles in the absence of disease progression or unacceptable toxicity. Participants may receive up to three additional cycles of treatment per physician discretion. Panitumumab: Given IV Talimogene Laherparepvec: Given IM
Investigations Alanine aminotransferase increased	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Investigations Creatinine increased	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Blood and lymphatic system disorders Lymph node pain	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Infections and infestations Rash pustular	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Nervous system disorders Dizziness	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Psychiatric disorders Insomnia	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Vascular disorders Thromboembolic event	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Diarrhea	60.0% 3/5 • Number of events 3 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Nausea	60.0% 3/5 • Number of events 4 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Abdominal pain	40.0% 2/5 • Number of events 2 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Constipation	40.0% 2/5 • Number of events 3 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Gastric hemorrhage	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
General disorders Fatigue	80.0% 4/5 • Number of events 10 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
General disorders Fever	40.0% 2/5 • Number of events 6 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
General disorders Chills	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
General disorders Pain	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Metabolism and nutrition disorders Anorexia	60.0% 3/5 • Number of events 3 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Metabolism and nutrition disorders Hypomagnesemia	40.0% 2/5 • Number of events 2 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Metabolism and nutrition disorders Hyperglycemia	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Skin and subcutaneous tissue disorders Rash acneiform	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Number of events 1 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.0% 1/5 • Number of events 2 • From date of enrollment to the date of death or progression, whichever occurred earlier assessed up to two years.

Additional Information

Dr. Adam Berger

Cancer Institute of New Jersey Rutgers

Phone: 732-235-8675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place