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

NCT04163952 | Terminated Phase 1 Results DMC FDA Drug

• 4 other identifiers: Pro2018002628NCI-2019-06083091804P30CA072720
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

This phase I trial studies the side effects and how well talimogene laherparepvec and panitumumab work in treating patients with squamous cell carcinoma of the skin that has spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic). Talimogene laherparepvec is a type of vaccine made from a gene-modified virus that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and panitumumab may work better in treating patients with squamous cell carcinoma of the skin compared to panitumumab alone.

Conditions

Metastatic Skin Squamous Cell Carcinoma; Recurrent Skin Squamous Cell Carcinoma; Locally Advanced Skin Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0

  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.

  Up to 30 days

• Response Rate to Panitumumab as Measured by Evaluation of the Criteria in Solid Tumors (RECIST) 1.1.

  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.

  Up to two years

Secondary Outcomes (14)

• Best Overall Response Rate (ORR) of Participants From Start to Progression of Disease

  Up to two years

• Durable Response Rate Based on Simons Two-stage Design

  Up to two years

• Duration of Response Based on Simons Two-stage Design

  Time from initial response until document progression up to two years

• 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

• 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

Study Arms (1)

Treatment (talimogene laherparepvec, panitumumab)

EXPERIMENTAL

Patients receive talimogene laherparepvec IM on day 1. Patients then receive talimogene laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive up to 3 additional cycles of treatment per physician discretion.

Biological: Panitumumab; Biological: Talimogene Laherparepvec

Interventions

Panitumumab BIOLOGICAL

Given IV

Also known as: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF, Monoclonal Antibody ABX-EGF, Vectibix

Treatment (talimogene laherparepvec, panitumumab)

Talimogene Laherparepvec BIOLOGICAL

Given IM

Also known as: ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene, Imlygic, JS1 34.5-hGMCSF 47- pA-, T-VEC

Treatment (talimogene laherparepvec, panitumumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous cell carcinoma of the skin (SCCS) that is a) locally advanced or metastatic for which curative surgery or radiation would be difficult or impossible, or b) recurrent after initial surgery, chemotherapy, or radiation therapy, or c) considered to have aggressive features including the following: tumors 2 cm or more, tumors invading deep tissues such as muscle, cartilage or bone; tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes. Patients may have had prior surgical interventions or been treated with investigational agents with residual or recurrent disease
• Tumor suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion, or aggregate of lesions, \>= 10 mm in diameter
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• No prior treatment with panitumumab or talimogene laherparepvec for advanced disease
• Prior surgery or radiation is allowed if there is documented progression in the radiated/resected area or elsewhere by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v) 1.1
• Measurable disease by RECIST criteria v 1.1
• Patients with a history of hematologic or solid organ transplant will be considered if they do not require high dose steroids or high dose immunosupressants for disease control or control of transplant rejection, and have adequate hematologic, renal, and hepatic function as specified below. Current medications must be reviewed with transplant pharmacy team to exclude potentially serious interactions and case discussed with the study principal investigator (PI)
• Second primary malignancy only if treatment would interfere with the patient?s participation in this trial in the opinion of the treating physician. Clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g., in situ carcinoma of the cervix) and, 3) additional skin cancers that have been definitively treated by surgery and/or radiation. Patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as intravenous immunoglobulin \[IVIG\] is permitted)
• Patients with autoimmune disorders will be considered if they do not require high dose steroids or other immunosuppressants for disease control. Prednisone in daily doses up to 10 mg and inhaled steroids are acceptable
• Absolute neutrophil count (ANC) \>= 1500/uL
• Platelet count \>= 100,000/mm\^2
• Hemoglobin \>= 9 g/dL
• Total bilirubin \< 1.5 x institutional upper limit of normal (ULN); if patient has conditions of congenital hyperbilirubinemia, then patient must have isolated hyperbilirubinemia (e.g., no other liver function test abnormalities) with maximum bilirubin \< 2 x institutional ULN
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x institutional ULN in absence of liver metastases; =\< 5 x ULN in presence of liver metastases
• Alkaline phosphatase \< 2.5 x institutional ULN

You may not qualify if:

• Pregnant women. Women of childbearing age must be willing to undergo a pregnancy test prior to therapy and to use adequate contraception (e.g., hormonal or barrier method of contraception or abstinence) for the duration of the study and 6 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Menopausal status will be defined as one or more of successful hysterectomy, bilateral tubal ligation or bilateral oophorectomy, amenorrhea \>= 12 consecutive months without another cause, or a documented serum follicle stimulating hormone (FSH) \>= 35 mIU/mL
• Tumor not suitable for direct or ultrasound-guided injection
• Prior treatment with talimogene laherparepvec for advanced disease
• Patients with active, uncontrolled infections including active herpetic infections or chronic herpetic infections requiring anti-viral therapy (e.g., acyclovir)
• Patients without adequate organ function as documented above
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab, talimogene laherparepvec or other agents used in the study
• History of interstitial pneumonitis, pulmonary fibrosis, or evidence of interstitial pneumonitis

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

NYU Langone Medical Center (Tisch Hospital)

New York, New York, 10016, United States

Location

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Panitumumab; talimogene laherparepvec

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Adam Berger
• Organization: Cancer Institute of New Jersey Rutgers

ab2047@cinj.rutger.edu

732-235-8675

Study Officials

• Adam C Berger, MD, FACS

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator is deceased - Professor and Chief of Melanoma and Soft Tissue Sarcoma

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 15, 2019
• Study Start: January 31, 2020
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 18, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)