Study of IPH2201 (Monalizumab) and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase II, Phase ITreatmentActive18 and overIPH2201-203
NCI-2016-00212, NCT02643550

Trial Description

Summary

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses

of IPH2201 given IV in combination with cetuximab in patients who have received prior

systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and

neck (SCCHN). A cohort expansion will evaluate antitumor activity of the combination.

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria:

1. Age ≥ 18 years

2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma

of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis,

glottis, subglottis) or oral cavity,

3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or

physical examination. In phase II, measurable disease as per Response Evaluation

Criteria in Solid Tumors [RECIST] 1.1 is mandated. In phase Ib, patients with or

without measurable disease are eligible.

4. Progression after platinum-based chemotherapy

5. For phase Ib only: Pretreated patients, and not amenable to further therapy with

curative intent. This part is open to pretreated patients regardless of the number of

previous treatment lines.

For phase II only: Patients who received a maximum of two prior systemic regimens for

recurrent and/or metastatic disease and not amenable to further therapy with curative

intent.

6. No prior treatment by cetuximab except if given for primary treatment (locally

advanced disease) with no progressive disease for at least 4 months following the end

of prior cetuximab treatment.

7. Recovery from prior surgery and recovery from adverse events to grade 1 or less

(except alopecia) due to prior radiation therapy and any systemic therapy.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

9. Life expectancy of ≥ 3 months

10. Patients with treated brain metastases are eligible if they are > 4 weeks from

therapy completion (including radiation and/or surgery), are clinically stable at the

time of study entry and are not receiving corticosteroid therapy at the time of study

entry

11. Adequate hematologic, immunologic, liver and renal function, defined as

hemoglobin ≥ 9.0 g/dL,

absolute neutrophil count ≥ 1,500/mm3,

platelets ≥ 100,000/mm3,

total bilirubin ≤ 1.5 X institutional upper normal limit (UNL),

aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X

institutional UNL,

serum creatinine ≤1.5 X institutional UNL or estimated (Cockcroft-Gault formula)

or measured creatinine clearance ≥ 50 mL/min

12. Negative serum pregnancy test within 72 hours before starting study treatment for

women of childbearing potential. Women of childbearing potential and all men must

agree to use adequate contraception (hormonal or barrier method of birth control;

abstinence) prior to study entry, for the duration of monalizumab administration and

for up to 5 months after the last dose of monalizumab.

13. Ability to understand a written informed consent document

14. Signed informed consent prior to any protocol-specific procedures

Exclusion Criteria:

1. For phase II only: Patients who received more than 2 prior systemic regimens for

recurrent and/or metastatic disease (no restriction in the phase Ib part of the

trial).

2. For phase II only: Patients who received cetuximab or another inhibitor of epidermal

growth factor receptor are excluded from the phase II of the trial, except if

cetuximab was given as part of a primary treatment approach, with no progressive

disease for at least 4 months following the end of prior cetuximab treatment.

3. History of allergic reactions attributed to compounds of similar chemical or biologic

composition to cetuximab.

4. Patients with known untreated and uncontrolled brain metastases are excluded.

However, brain-imaging studies are not required for eligibility if the patient has no

neurological signs or symptoms.

5. Serious concurrent uncontrolled medical disorder.

6. Auto-immune disease, which:

1. currently or previously required systemic immunosuppressive or immunomodulatory

therapy (including corticosteroids administered by systemic route) and/or

2. has a substantial probability to cause an irreversible injury to any tissue

and/or

3. has been diagnosed less than 3 months before study entry and/or

4. is clinically unstable and/or

5. has a substantial risk to progress and cause severe complications.

7. Abnormal cardiac status with any of the following:

1. Unstable angina

2. Arrhythmia requiring treatment which is

Exclusion Criteria:

Inclusion Criteria:

1. Age ≥ 18 years

2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma

of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis,

glottis, subglottis) or oral cavity,

3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or

physical examination. In phase II, measurable disease as per Response Evaluation

Criteria in Solid Tumors [RECIST] 1.1 is mandated. In phase Ib, patients with or

without measurable disease are eligible.

4. Progression after platinum-based chemotherapy

5. For phase Ib only: Pretreated patients, and not amenable to further therapy with

curative intent. This part is open to pretreated patients regardless of the number of

previous treatment lines.

For phase II only: Patients who received a maximum of two prior systemic regimens for

recurrent and/or metastatic disease and not amenable to further therapy with curative

intent.

6. No prior treatment by cetuximab except if given for primary treatment (locally

advanced disease) with no progressive disease for at least 4 months following the end

of prior cetuximab treatment.

7. Recovery from prior surgery and recovery from adverse events to grade 1 or less

(except alopecia) due to prior radiation therapy and any systemic therapy.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

9. Life expectancy of ≥ 3 months

10. Patients with treated brain metastases are eligible if they are > 4 weeks from

therapy completion (including radiation and/or surgery), are clinically stable at the

time of study entry and are not receiving corticosteroid therapy at the time of study

entry

11. Adequate hematologic, immunologic, liver and renal function, defined as

hemoglobin ≥ 9.0 g/dL,

absolute neutrophil count ≥ 1,500/mm3,

platelets ≥ 100,000/mm3,

total bilirubin ≤ 1.5 X institutional upper normal limit (UNL),

aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X

institutional UNL,

serum creatinine ≤1.5 X institutional UNL or estimated (Cockcroft-Gault formula)

or measured creatinine clearance ≥ 50 mL/min

12. Negative serum pregnancy test within 72 hours before starting study treatment for

women of childbearing potential. Women of childbearing potential and all men must

agree to use adequate contraception (hormonal or barrier method of birth control;

abstinence) prior to study entry, for the duration of monalizumab administration and

for up to 5 months after the last dose of monalizumab.

13. Ability to understand a written informed consent document

14. Signed informed consent prior to any protocol-specific procedures

Exclusion Criteria:

1. For phase II only: Patients who received more than 2 prior systemic regimens for

recurrent and/or metastatic disease (no restriction in the phase Ib part of the

trial).

2. For phase II only: Patients who received cetuximab or another inhibitor of epidermal

growth factor receptor are excluded from the phase II of the trial, except if

cetuximab was given as part of a primary treatment approach, with no progressive

disease for at least 4 months following the end of prior cetuximab treatment.

3. History of allergic reactions attributed to compounds of similar chemical or biologic

composition to cetuximab.

4. Patients with known untreated and uncontrolled brain metastases are excluded.

However, brain-imaging studies are not required for eligibility if the patient has no

neurological signs or symptoms.

5. Serious concurrent uncontrolled medical disorder.

6. Auto-immune disease, which:

1. currently or previously required systemic immunosuppressive or immunomodulatory

therapy (including corticosteroids administered by systemic route) and/or

2. has a substantial probability to cause an irreversible injury to any tissue

and/or

3. has been diagnosed less than 3 months before study entry and/or

4. is clinically unstable and/or

5. has a substantial risk to progress and cause severe complications.

7. Abnormal cardiac status with any of the following:

1. Unstable angina

2. Arrhythmia requiring treatment which is

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Innate Pharma

    Trial Sites

    U.S.A.

    California
    Palo Alto

    Stanford Cancer Institute

    Alexander Dimitrios Colevas
    Principal Investigator

    Colorado
    Aurora

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Antonio Jimeno
    Principal Investigator

    New York
    New York

    Icahn School of Medicine at Mount Sinai

    Marshall Roy Posner
    Principal Investigator

    Pennsylvania
    Philadelphia

    Fox Chase Cancer Center

    Jessica Ruth Bauman
    Principal Investigator

    University of Pennsylvania/Abramson Cancer Center

    Roger Bryan Cohen
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT02643550

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.