Phase II Study of efti plus pembrolizumab combination therapy for head and neck cancer (HNSCC).

Phase 1

• Conditions: Metastatic head and neck squamous cell carcinoma (HNSCC); MedDRA version: 27.0Level: PTClassification code: 10071540Term: Head and neck cancer metastatic Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-510762-16-00
• Lead Sponsor: Immutep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

Willing to give written informed consent and to comply with the protocol., Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Lesions situated in a previously irradiated area is considered measurable if progression has been demonstrated in such lesions., Subjects who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Subjects should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of trial intervention.Hepatitis B screening test are not required unless: a) known history of HBV infection. b) mandated by local health authority., Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening., HIV infected subjects must be on anti-retroviral therapy and have a well-controlled HIV infection/disease defined as: a) Subjects on ART must have a CD4+ T-cell count >350 cells/mm3 at time of screening b) Subjects on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening c) Subjects on ART must have been on stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to cycle 1 day 1 Note: no HIV testing is required unless mandated by local health authority., Laboratory criteria: a) Absolute neutrophil count > 1.5 x 10^9/L b) Platelet count = 100 x 10^9/L c) Hemoglobin = 9 g/dL or 5.58 mmol/L d) Serum creatinine = 1.5 × ULN, or if > 1.5 ULN with a clearance of = 50 mL/min acc. to Gault-Cockcroft formula e) Total bilirubin = 1.5 x ULN or direct bilirubin = ULN for subjects with total bilirubin > 1.5 x ULN Note: subjects with known Gilbert's syndrome can be enrolled. f) AST (=SGOT) and ALT (=SGPT) = 2.5 x ULN or = 5 x ULN if liver metastases are present. g) International normalized ratio (INR) or prothrombin time (PT) =1.5 ×ULN unless subject is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants, Histologically- or cytologically confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies and to be treated in the first line palliative setting and who are PD-X naïve., Availability of tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days prior to start of trial treatment) is preferred but an archival sample is acceptable., Availability of PD-L1 biomarker result by using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx), Availability of tissue for testing of human papillomavirus (HPV) status for oropharyngeal carcinoma (p16 expression testing). Note: If HPV status was previously tested using this method and result isavailable, no additional testing in central laboratory is required for this trial., Female or male =18 years of age on the day of signing the informed consent., All female subjects o

Exclusion Criteria

Disease is suitable for local therapy administered with curative intent, Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery, another systemic cancer therapy or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to cycle 1 day 1., Known active central nervous system metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable: i.e. without evidence of progression documented by repeat imaging performed after therapy completed for CNS metastasis and with at least 4 weeks difference, clinically stable and without requirement for steroid treatment for at least 14 days prior to cycle 1 day 1., Pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the trial starting with screening visit. A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to cycle 1 day 1., Serious intercurrent infection within 4 weeks prior to cycle 1 day 1 or active acute or chronic infection., Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade = 2, atrial fibrillation > grade 2 not controlled by a pacemaker, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism., Has interstitial lung disease or history of (non-infectious) pneumonitis that required steroids or has current pneumonitis., Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form ofsystemic treatment and is allowed., HIV-infected subjects with a history of Kaposi sarcoma and/or Multicentric Castleman Disease., Has a life-threatening illness unrelated to cancer., Has had an allogenic tissue/solid organ transplant., Previously treated with = 1 systemic regimen for recurrent and/or metastatic disease (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally or locoregionally advanced disease), Has previous malignancies within the last three years other than described in inclusion criterion 2,except curatively treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, ductal carcinoma in situ of the breast, or in situ carcinoma of the cervix., Receives continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease., Has a hypersensitivity to efti and/or pembrolizumab and/or any of its excipients., Live vaccine within 30 days of planned cycle 1 day 1., Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified