Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck

Browse trials for

• Carcinoma 6,741
• Carcinoma, Squamous Cell 1,772

Keywords

• Squamous Cell Carcinoma in Head and Neck
• Prior Platinum-based chemotherapy
• Cetuximab
• Erbitux
• IMC-A12

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 97 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  IMC-A12 (cixutumumab)

  Biological: IMC-A12 (cixutumumab)

• Experimental
  IMC-A12 (cixutumumab) + cetuximab

  Biological: IMC-A12 (cixutumumab) · Biological: cetuximab (Erbitux ®)

Interventions

• BiologicalIMC-A12 (cixutumumab)

  IMC-A12 10 milligrams per kilogram (mg/kg) over one hour every two weeks. A cycle is defined as four weeks of therapy. Participants will continue on study until evidence of progressive disease, or unacceptable toxicity develops.

  Also known as: Cixutumumab, LY3012217

• Biologicalcetuximab (Erbitux ®)

  IMC-A12 10 mg/kg over one hour followed by cetuximab 500 milligrams per square meter (mg/m\^2) over two hours. This sequence will be repeated every two weeks. Participants will continue on study until evidence of progressive disease or unacceptable toxicity develops.

  Also known as: Erbitux®

Primary outcomes

1. Progression-Free Survival (PFS)

   PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.

   Time frame: Baseline to measured PD (up to 27.66 months)

Secondary outcomes

1. Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

   ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.

   Time frame: Baseline to measured PD (up to 27.66 months)

2. Percentage of Participants With PFS at 6 Months

   PFS at 6 months was defined as the percentage of participants who have neither experienced PD nor died at 6 months after the date of randomization. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 6 months divided by the total number of participants treated then multiplied by 100.

   Time frame: 6 months

3. Overall Survival (OS)

   OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.

   Time frame: Baseline to date of death from any cause (up to 29.63 months)

4. Duration of Response

   The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of PD or death. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of PD.

   Time frame: Date of first response to the date of PD or death due to any cause (up to 23.98 months)

5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths

   TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs including serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events section of this report.

   Time frame: Baseline through study completion (up to 29.63 months)

6. Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab

   No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay.

   Time frame: Biomarkers [pre-dose, Cycle 1 (Day 15), (Cycle 2 (Day 1), and end of treatment]; Immunogenicity [pre-dose, prior to first infusion for Cycle 3, Cycle 5, and 30-day safety follow-up]

Baseline characteristics

2 further baseline measures are reported on the registry.