Phase II Study of IMP321 plus pembrolizumab in non-small cell lung cancer (NSCLC) or head and neck cancer (HNSCC)
- Conditions
- Previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC), or recurrent PD-X refractory NSCLC or recurrent or metastatic squamous head and neck cancer (HNSCC)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10071540Term: Head and neck cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2018-001994-25-GB
- Lead Sponsor
- Immutep S.A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 183
1. Willing to give written informed consent and to comply with the protocol.
2.1 Part A (1st line, PD-X naïve in metastatic setting NSCLC): histologically- or cytologically confirmed diagnosis of non-small cell lung carcinoma stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable).
Part B (2nd line, PD-X refractory NSCLC): histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic/advanced disease) with at least 2 cycles of any PD-1/PD-L1 containing based therapy (e.g. nivolumab, pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other immunotherapeutic or chemotherapy given as part of first-line treatment.
Part C (2nd line PD-X naive HNSCC): 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 after failure of prior platinum-based therapy.
3. Availability of formalin-fixed diagnostic tumor tissue (in the case of participants having received adjuvant therapy, the tissue should be taken after completion of this therapy)
4. Female or male =18 years of age on the day of signing the informed consent.
5. All female patients of childbearing potential must have a negative highly sensitive pregnancy test at screening (within 72 hours prior to cycle 1 day 1); all patients of reproductive potential must agree to use highly effective method for contraception from study entry until at least 4 months after the last administration of any study treatment.
A woman must either be,
• not of childbearing potential: postmenopausal (= 60 years of age, or < 60 years of age and amenorrhoeic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L, or if taking tamoxifen or toremifene, and age < 60 years, then FSH and estradiol in the postmenopausal range), permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), or otherwise incapable of pregnancy
•Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; male partner sterilization (the vasectomized partner should be the sole partner for that subject).
6. A man who is sexually active and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom or partner with occlusive cap (diaphragm or cervical/vault caps) from study entry until at least 4 months after the last administration of study treatment. All men must also not donate sperm from time of study entry until at least 4 months after the last administration of study treatment.
7. ECOG performance status 0-1.
8. Expected survival > 3 months.
9. Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 modified for immune-bas
1.1 Part A (1st line, PD-X naïve in metastatic setting NSCLC):
NSCLC can be treated with curative intent with either surgical resection and/or chemoradiation and/or radiation.
Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
EGFR-sensitizing mutation and/or is echinoderm microtubule-associated protein-like 4(EML4) gene/anaplastic lymphoma kinase (ALK) gene fusion positive (ALK translocation).
- Has received lung radiation therapy that is >30Gy within 6 months of the first dose of trial treatment.
Part B (2nd line, PD-X refractory NSCLC):
Symptomatic ascites or pleural effusion.
>1 line of any systemic anticancer therapy for advanced or metastatic disease.
- Has received lung radiation therapy that is >30Gy within 6 months of the first dose of trial treatment.
Part C (2nd line PD-X naive HNSCC):
Disease is suitable for local therapy administered with curative intent.
Previously treated with > 1 systemic regimen for recurrent and/or metastatic disease.
2. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) (Part A and C only)
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE (Part B only)
4. No tumor specimen evaluable for PD-L1 expression by the central study laboratory.
5.1 Prior anti LAG-3 therapy.
6. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
7. Prior targeted small molecule therapy, or radiation therapy within 2 weeks prior to cycle 1 day 1
8.1 Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery, another systemic cancer therapy or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to cycle 1 day 1.
9. Known active CNS metastasis and/or carcinomatous meningitis. Patients 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.
10. Women who are pregnant or lactating. A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to cycle 1 day 1.
11. Serious intercurrent infection within 4 weeks prior to cycle 1 day 1 or active acute or chronic infection.
12.1 Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of study treatment.
13. Has interstitial lung disease or history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
14. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method