Phase 2
Completed N=97
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
Source: ClinicalTrials.gov NCT00617734 ↗Enrolled (actual)
97
Serious AEs
47.3%
Results posted
Apr 2018
Primary outcomePrimary: Progression-Free Survival (PFS) — 1.9; 2.0 months — p=0.0667
Summary
The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
1.9; 2.0 | 0.0667 |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] |
2.1; 9.1 | 0.1935 |
| SECONDARY Percentage of Participants With PFS at 6 Months |
4.3; 13.6 | — |
| SECONDARY Overall Survival (OS) |
5.3; 5.5 | 0.7455 |
| SECONDARY Duration of Response |
12.8; 6.2 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths |
47; 44; 20; 23; 2; 6 | — |
| SECONDARY Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical imaging studies
- Measurable disease, lesion size ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
- Clinical documentation of disease progression during treatment with or within 90 days after receiving the last cycle of platinum-based chemotherapy (with or without radiation therapy)
- If prior treatment with anti-epidermal growth factor receptor (EGFR) therapy, the time to recurrence from last exposure to anti-EGFR therapy is > 90 days
- Adequate hematologic function
- Adequate hepatic function
- Adequate coagulation function or is on a stable dose of an anticoagulant.
- Adequate renal function
- Fasting serum glucose <120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria
- Not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, must have recovered to grade ≤ 2
- Is receiving any other investigational agent(s)
- History of treatment with other agents targeting the insulin-like growth factor receptor (IGFR)
- Is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or IMC-A12
- Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
- Pregnant or breastfeeding
- Is receiving therapy with immunosuppressive agents
Data sourced from ClinicalTrials.gov (NCT00617734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.