Talimogene Laherparepvec + Panitumumab for Skin Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Antivirals

Disqualifiers: Pregnancy, Uncontrolled infections, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6-12 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Adam Berger

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

Adults with advanced or metastatic squamous cell carcinoma of the skin, not treatable by surgery or radiation, may join. They should have measurable disease and be in relatively good health without severe autoimmune disorders or a need for high-dose steroids. Prior treatments are okay if there's documented cancer progression. Pregnant women and those unwilling to use contraception are excluded.

Inclusion Criteria

You have had another type of cancer in the past, but it won't affect your participation in this trial unless your treating physician thinks it might. Exceptions include cancers that have been treated and gone into remission for at least three years, in situ carcinoma (like cervical cancer), and skin cancers that have been treated with surgery or radiation. If you have chronic lymphocytic leukemia, you can participate if your blood counts are normal and you're not currently receiving cytotoxic or biologic anticancer treatment, except for supportive treatment like IVIG.

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

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)

Exclusion Criteria

Tumor not suitable for direct or ultrasound-guided injection

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

Prior treatment with talimogene laherparepvec for advanced disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talimogene laherparepvec intratumorally on day 1 and then talimogene laherparepvec and panitumumab intravenously on day 22. Treatment repeats every 2 weeks for up to 3 cycles, with the possibility of 3 additional cycles.

6-12 weeks

Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 2 months for 2 years.

2 years

Every 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Panitumumab
• Talimogene Laherparepvec

Trial Overview The trial is testing talimogene laherparepvec (a gene-modified virus vaccine) combined with panitumumab (an antibody therapy) against squamous cell carcinoma of the skin. It aims to see if this combo is more effective than panitumumab alone in treating this type of cancer.

How Is the Trial Designed?

Group I: Treatment (talimogene laherparepvec, panitumumab) Experimental Treatment 2 Interventions

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.

Panitumumab is already approved in European Union, United States for the following indications:

Approved in European Union as Vectibix for:

• Metastatic colorectal cancer (mCRC) with wild-type KRAS

Approved in United States as Vectibix for:

• Metastatic colorectal cancer (mCRC) with wild-type KRAS

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+