NCT03254927 · REGISTRY CONDITION SEARCH

A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2023-04-03

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Clinical Benefit Response (CBR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Incidence of Adverse Events [Safety and Tolerability]

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outcome · POSTED

Tumor DNA Biomarkers.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Histologically or cytologically confirmed head and neck squamous cell carcinoma. 2. Human papilloma virus (HPV) negative tumor. 3. Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate. 4. Prior treatment with cetuximab with tumor progression during or within 6 months after completing treatment. 5. Measurable disease. 6. Life expectancy ≥ 12 weeks. 7. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment. 8. Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue). Exclusion Criteria: 1. Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents. 2. Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed. 3. Major surgery within 4 weeks prior to first dose of study treatment. 4. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment. 5. Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment. 6. Other prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast. 7. Active, untreated central nervous system metastases. 8. Active autoimmune disease or documented history of autoimmune disease. 9. Significant cardiovascular disease including CHF or poorly controlled hypertension.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.
intervention Names
Drug: CDX-3379 and cetuximab
label
CDX-3379 and cetuximab
type
EXPERIMENTAL

interventions

arm Group Labels
CDX-3379 and cetuximab
description
Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
name
CDX-3379 and cetuximab
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The percentage of patients who achieve a complete response or partial response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
measure
Objective Response Rate
time Frame
The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.

secondary Outcomes

description
The percentage of patients who achieve best response of confirmed CR or PR, or stable disease (SD) for at least 12 weeks
measure
Clinical Benefit Response (CBR)
time Frame
Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years
description
The interval from which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) until the first date that progressive disease is objectively documented
measure
Duration of Response (DOR)
time Frame
First occurrence of a documented objective response to disease progression or death (up to approximately 2 years)
description
The time from start of study drug to time of progression or death, whichever occurs first
measure
Progression-free Survival (PFS)
time Frame
From first dose to the first occurrence of disease progression or death due to any cause (up to approximately 2 years)
description
The time from start of study drug to death
measure
Overall Survival (OS)
time Frame
The time from start of study drug to death from any cause (up to approximately 2 years)
description
Safety and tolerability of CDX-3379 in combination with cetuximab as determined by incidence and severity of adverse events. Percentage of patients reporting one or more adverse events.
measure
Incidence of Adverse Events [Safety and Tolerability]
time Frame
Following at least one dose of study treatment through 30 days after last dose of CDX-3379.
description
Tumor DNA biomarkers will be evaluated and assessed for correlation with clinical efficacy. Objective response rate for subset of patients with FAT1 positive tumor is reported.
measure
Tumor DNA Biomarkers.
time Frame
Tumor tissue is obtained during screening window via single biopsy procedure.

Full study description

brief Summary: This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.
detailed Description: CDX-3379 is a fully human monoclonal antibody that binds to a molecule called human epidermal growth factor receptor 3 (HER3 or ErbB3) found on certain cells and may act to promote anti-tumor effects. Cetuximab is a human monoclonal antibody that blocks EGFR, a protein receptor that regulates cell growth. This study will evaluate the safety, tolerability and efficacy of CDX-3379 in combination with cetuximab in patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed. Eligible patients that enroll in the study will be given the dose of 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab. Up to 45 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

Source references

references

citation
Duvvuri U, George J, Kim S, Alvarado D, Neumeister VM, Chenna A, Gedrich R, Hawthorne T, LaVallee T, Grandis JR, Bauman JE. Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients. Clin Cancer Res. 2019 Oct 1;25(19):5752-5758. doi: 10.1158/1078-0432.CCR-18-3453. Epub 2019 Jul 15.
pmid
31308059
type
DERIVED

Source notices and limitations

Discovery and provenance

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query disease state id
ds-laryngeal-cancer
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source kind
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source url
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Preserved source evidence · Not medical advice