Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT07042295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial compares the effect of amivantamab and hyaluronidase to cetuximab for the treatment of skin (cutaneous) squamous cell carcinoma that has come back after a period of improvement and has not spread to other parts of the body (locally recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Amivantamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Hyaluronidase is an endoglycosidase. It helps to keep amivantamab in the body longer, so that the medications will have a greater effect. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving amivantamab and hyaluronidase may be as effective as cetuximab for the treatment of locally recurrent or metastatic cutaneous squamous cell carcinoma.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the safety and preliminary efficacy of amivantamab monotherapy in patients with locoregionally incurable or metastatic cutaneous squamous cell carcinoma and an active immunosuppressed condition. (Cohort A) II. To compare progression-free survival (PFS) of amivantamab monotherapy versus cetuximab monotherapy in patients with locoregionally incurable or metastatic cutaneous squamous cell carcinoma and an active immunosuppressed condition. (Cohort B)
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of toxicities in each cohort and treatment arm.
II. To estimate confirmed objective response rate (ORR) (ORR, confirmed complete and partial responses by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) in each cohort and treatment arm.
III. To estimate duration of objective response, time to progression, time to next treatment, and overall survival in each cohort and treatment arm.
IV. To estimate ORR and progression free survival (PFS) in each cohort and treatment arm in subgroups defined by reason for immunosuppression: transplant, autoimmune disease, hematologic malignancy, or other reason.
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE: Patients in cohort A are assigned to arm I, patients in cohort B are randomized to arm I or II.
ARM I: Patients receive amivantamab and hyaluronidase subcutaneously (SC) over at least 5 minutes on days 1, 8, 15 and 22 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.
ARM II: Patients receive cetuximab intravenously (IV) over 60-120 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT and/or MRI throughout the study.
After completion of study treatment, patients are followed up, per the treating investigator, for up 3 years.
I. To evaluate the safety and preliminary efficacy of amivantamab monotherapy in patients with locoregionally incurable or metastatic cutaneous squamous cell carcinoma and an active immunosuppressed condition. (Cohort A) II. To compare progression-free survival (PFS) of amivantamab monotherapy versus cetuximab monotherapy in patients with locoregionally incurable or metastatic cutaneous squamous cell carcinoma and an active immunosuppressed condition. (Cohort B)
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of toxicities in each cohort and treatment arm.
II. To estimate confirmed objective response rate (ORR) (ORR, confirmed complete and partial responses by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) in each cohort and treatment arm.
III. To estimate duration of objective response, time to progression, time to next treatment, and overall survival in each cohort and treatment arm.
IV. To estimate ORR and progression free survival (PFS) in each cohort and treatment arm in subgroups defined by reason for immunosuppression: transplant, autoimmune disease, hematologic malignancy, or other reason.
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE: Patients in cohort A are assigned to arm I, patients in cohort B are randomized to arm I or II.
ARM I: Patients receive amivantamab and hyaluronidase subcutaneously (SC) over at least 5 minutes on days 1, 8, 15 and 22 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.
ARM II: Patients receive cetuximab intravenously (IV) over 60-120 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT and/or MRI throughout the study.
After completion of study treatment, patients are followed up, per the treating investigator, for up 3 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-04318 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| SN2426 | OTHER | SWOG | View | |
| SN2426 | OTHER | CTEP | View | |
| U10CA180888 | NIH | None | https://reporter.nih.gov/quic… | View |