Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers Including Oropharyngeal SCCHN

NCT03260023

Last updated date
Study Location
Granada
Granada, , , Spain
Contact
+ 33 (0) 3 88 27 91 00

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Head and Neck Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female or male patients, aged at least 18 years (no upper limit of age)

- ECOG PS 0 or 1

- Life expectancy of at least 3 months

- Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer: cervical, vulvar, vaginal, penile, anal, and oropharyngeal squamous cell carcinoma of head and neck.

- Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression

- Prior therapy: Patients MAY have received up to 2 prior lines of systemic chemotherapy for the management of metastatic or recurrent disease; for SCCHN, patients MUST have previously been exposed to platinum-based therapy, either as part of definitive chemo-radiation OR as first line systemic treatment for metastatic disease which may include cetuximab. Patients with recurrence/progression within 6 months of prior multimodal therapy using platinum-based therapy are eligible. Patients with cervical cancer may have undergone surgery and/or received definitive radiation or chemo-radiation therapy for localized disease.

- Availability of tumor tissue from biopsy

- At least one measurable lesion by CT scan according to RECIST 1.1.

- Adequate hematological, hepatic and renal function

- Negative blood pregnancy test at screening for women of childbearing potential

- Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug
targeting T cell co-regulatory proteins (immune checkpoints)


- Patients under chronic treatment with systemic corticosteroids or other
immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not
stopped 2 weeks prior to the first study treatment, with the exception of patients
with adrenal insufficiency who may continue corticosteroids at physiological
replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal
systemic effect (topical, inhalation) are allowed


- Patients with CNS metastases except those with brain metastases treated locally and
clinically stable during 4 weeks prior to start of study treatment, and those without
ongoing neurological symptoms that are related to the brain localization of the
disease


- Other active malignancy requiring concurrent systemic intervention


- Patients with previous malignancies other than the target malignancy to be
investigated in this trial (except non-melanoma skin cancers, and the following in
situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or
breast) are excluded unless a complete remission was achieved at least 2 years prior
to study entry AND no additional therapy is required during the study period


- Patient with any organ transplantation, including allogeneic stem cell transplantation


- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC
V4.03), any history of anaphylaxis, or uncontrolled asthma


- Any known allergy or reaction to eggs, gentamycin or attributed to compounds of
similar chemical or biological composition to therapeutic vaccines/immunotherapeutic
products


- Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients


- Patients with history of interstitial lung disease


- Patients with active, known, or suspected auto-immune disease or immunodeficiency,
except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or
skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment


- Clinically significant (that is, active) cardiovascular disease: cerebral vascular
accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable
angina pectoris, congestive heart failure (New York Heart Association Classification
Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication/active
intervention


- History of uncontrolled intercurrent illness including but not limited to:


- Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or
lower)


- Uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%)

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Head and Neck Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related CarcinomaPhase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers Including Oropharyngeal SCCHN
NCT03260023
  1. Granada,
  2. Angers,
  3. Colmar,
  4. Lyon,
  5. Marseille,
  6. Nantes,
  7. Paris,
  8. Strasbourg,
  9. Toulouse,
  10. Madrid,
  11. Malaga,
  12. Valencia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers Including Oropharyngeal SCCHN
Official Title  ICMJE A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies Including Oropharyngeal Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Brief Summary

The study will consist of two parts :

In the phase Ib part: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation.

In the phase II part, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed.

In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.

All patients will be followed up until disease progression or death due to any cause or the date of data cut-off, whichever occurs first.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Head and Neck Squamous Cell Carcinoma
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Related Carcinoma
Intervention  ICMJE
  • Biological: TG4001
    PhIb Dose escalation PhII established RP2D of the combination
  • Drug: Avelumab
    Anti PD-L1
Study Arms  ICMJE Experimental: TG4001/Avelumab
Interventions:
  • Biological: TG4001
  • Drug: Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2017)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female or male patients, aged at least 18 years (no upper limit of age)
  • ECOG PS 0 or 1
  • Life expectancy of at least 3 months
  • Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer: cervical, vulvar, vaginal, penile, anal, and oropharyngeal squamous cell carcinoma of head and neck.
  • Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression
  • Prior therapy: Patients MAY have received up to 2 prior lines of systemic chemotherapy for the management of metastatic or recurrent disease; for SCCHN, patients MUST have previously been exposed to platinum-based therapy, either as part of definitive chemo-radiation OR as first line systemic treatment for metastatic disease which may include cetuximab. Patients with recurrence/progression within 6 months of prior multimodal therapy using platinum-based therapy are eligible. Patients with cervical cancer may have undergone surgery and/or received definitive radiation or chemo-radiation therapy for localized disease.
  • Availability of tumor tissue from biopsy
  • At least one measurable lesion by CT scan according to RECIST 1.1.
  • Adequate hematological, hepatic and renal function
  • Negative blood pregnancy test at screening for women of childbearing potential
  • Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration

Exclusion Criteria:

  • Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
  • Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ? 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
  • Patients with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease
  • Other active malignancy requiring concurrent systemic intervention
  • Patients with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
  • Patient with any organ transplantation, including allogeneic stem cell transplantation
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ? 3 NCI-CTC V4.03), any history of anaphylaxis, or uncontrolled asthma
  • Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products
  • Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients
  • Patients with history of interstitial lung disease
  • Patients with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment
  • Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ? II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention
  • History of uncontrolled intercurrent illness including but not limited to:

    • Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower)
    • Uncontrolled diabetes (e.g., hemoglobin A1c ? 8%)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Transgene EU, Clinical Operations Department+ 33 (0) 3 88 27 91 00[email protected]
Listed Location Countries  ICMJE France,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03260023
Other Study ID Numbers  ICMJE TG4001.12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Transgene
Study Sponsor  ICMJE Transgene
Collaborators  ICMJE
  • Merck KGaA, Darmstadt, Germany
  • EMD Serono Research & Development Institute, Inc.
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account Transgene
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP