Informations générales (source: ClinicalTrials.gov)
Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma (IMMUQ)
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mai 2018
mai 2028
29 juin 2024
The main objective will be to estimate the disease free survival (DFS) of patients with
resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in
combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance
immunotherapy in order to compare it to historical DFS results of this kind of patients
treated by surgery and radiotherapy. Our primary end-point will be disease-free survival
at 2 years
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Soumya ANANE | 29/03/2024 01:28:38 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 24/02/2024 11:47:32 | Contacter | ||
Critères
Tous
Inclusion Criteria:
1. Be willing and able to provide written informed consent/assent for the trial.
2. Be >/= 18 years of age on day of signing informed consent.
3. Present with a resectable head and neck mucosal melanoma.
4. Be eligible for surgical treatment (without any contraindications).
5. Be eligible for adjuvant radiotherapy.
6. Have measurable disease based on RECIST 1.1.
7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a
tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42
days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained
samples cannot be provided (e.g. inaccessible or subject safety concern) may submit
an archived specimen only upon agreement from the Sponsor.
8. Have a performance status of 0 or 1 on the ECOG Performance Scale.
9. Demonstrate adequate organ function as defined in table 1, all screening labs should
be performed within 10 days of treatment initiation.
10. Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication. If
the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required.
11. Female subjects of childbearing potential should be willing to use 2 methods of
birth control or be surgically sterile, or abstain from heterosexual activity for
the course of the study through 120 days after the last dose of study medication.
Subjects of childbearing potential are those who have not been surgically sterilized
or have not been free from menses for > 1 year.
12. Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 120 days after the last dose of study
therapy.
13. Patient affiliated to a social security system or beneficiary of the same
For the cohort B, patients must met the following additional criteria :
14. Not having any contraindication for lenvatinib treatment
1. Be willing and able to provide written informed consent/assent for the trial.
2. Be >/= 18 years of age on day of signing informed consent.
3. Present with a resectable head and neck mucosal melanoma.
4. Be eligible for surgical treatment (without any contraindications).
5. Be eligible for adjuvant radiotherapy.
6. Have measurable disease based on RECIST 1.1.
7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a
tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42
days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained
samples cannot be provided (e.g. inaccessible or subject safety concern) may submit
an archived specimen only upon agreement from the Sponsor.
8. Have a performance status of 0 or 1 on the ECOG Performance Scale.
9. Demonstrate adequate organ function as defined in table 1, all screening labs should
be performed within 10 days of treatment initiation.
10. Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication. If
the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required.
11. Female subjects of childbearing potential should be willing to use 2 methods of
birth control or be surgically sterile, or abstain from heterosexual activity for
the course of the study through 120 days after the last dose of study medication.
Subjects of childbearing potential are those who have not been surgically sterilized
or have not been free from menses for > 1 year.
12. Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 120 days after the last dose of study
therapy.
13. Patient affiliated to a social security system or beneficiary of the same
For the cohort B, patients must met the following additional criteria :
14. Not having any contraindication for lenvatinib treatment
1. Is currently participating and receiving study therapy or has participated in a
study of an investigational agent and received study therapy or used an
investigational device within 4 weeks of the first dose of treatment.
2. Has a metastatic disease.
3. Has a non resectable melanoma.
4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (except
topical or inhaled steroids) or any other form of immunosuppressive therapy within 2
weeks prior to the first dose of trial treatment.
5. Has a known history of active TB (Bacillus Tuberculosis)
6. Hypersensitivity to pembrolizumab or any of its excipients.
7. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to D1 of
study treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from
adverse events due to agents administered more than 4 weeks earlier.
8. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 4 weeks or 5 half-life times (whatever the shorter) prior to study Day 1 or
who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a
previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and
may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately
from the toxicity and/or complications from the intervention prior to starting
therapy.
9. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of
the skin that has undergone potentially curative therapy or in situ cervical cancer.
10. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases may participate
provided they are stable (without evidence of progression by imaging for at least
four weeks prior to the first dose of trial treatment and any neurologic symptoms
have returned to baseline), have no evidence of new or enlarging brain metastases,
and are not using steroids for at least 7 days prior to trial treatment. This
exception does not include carcinomatous meningitis which is excluded regardless of
clinical stability.
11. Has active autoimmune and/or immune mediated inflammatory disease that has required
systemic treatment in the past 2 years (i.e. with use of disease modifying agents,
corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment.
12. Has known history of, or any evidence of active, non-infectious pneumonitis.
13. Has an active infection requiring systemic therapy.
14. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
15. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
16. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment.
17. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD L2 agent.
18. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
19. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).
20. Has received a live vaccine within 30 days of planned start of study therapy. Note:
Seasonal influenza vaccines for injection are generally inactivated flu vaccines and
are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
attenuated vaccines, and are not allowed.
21. Major injuries and/or surgery within the past 4 weeks prior to start of study
treatment with incomplete wound healing
22. Has a prior history of organ transplant including allogeneic stem cell transplant
23. Has a LVEF below the institutional (or local laboratory) normal range, as determined
by multigated acquisition (MUGA) or echocardiogram (ECHO)
24. Has an uveal melanoma
For the cohort B, patients must be excluded if one of the following additional
criteria is met :
25. Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite
of an optimized regimen of antihypertensive medication
26. Electrolyte abnormalities that have not been corrected
27. Significant cardiovascular impairment: history of congestive heart failure greater
than New York Heart Association (NYHA) Class II, unstable angina, myocardial
infarction or stroke within 12 months of the first dose of study drug, or cardiac
arrhythmia requiring medical treatment at Screening
28. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The
degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery)
should be considered because of the potential risk of severe hemorrhage associated
with tumor shrinkage/necrosis following lenvatinib therapy
29. Subjects having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine
collection for quantitative assessment indicates that the urine protein is <1 g/24
hours.
30. Subjects who have not recovered adequately from any toxicity from other anti- cancer
treatment regimens and/or complications from major surgery prior to starting
therapy. Withhold lenvatinib for at least 1 week prior to elective surgery. Do not
administer for at least 2 weeks following major surgery and until adequate wound
healing.
31. The participant has severe hypersensitivity (≥Grade 3) to lenvatinib and/or any of
its excipients.
32. Has presence of a gastrointestinal condition including malabsorption,
gastrointestinal, anastomosis, or any other condition that might affect the
absorption of lenvatinib.
33. Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
34. Has clinically significant hemoptysis or significant tumor bleeding within 3 weeks
prior to the first dose of study drug.
35. Prolongation of QTcF interval to >480 ms