NCT07277231Phase 3Recruiting
BeOne Medicines · City of Hope National Medical Center, Duarte, California
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Eligibility: 18 Years to · All · * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
* Measurable disease by Computer Tomography/Magnetic Resonance Imaging
* Adequate bone marrow and organ function
NCT07109219Phase 1, Phase 2Recruiting
AstraZeneca · Research Site, Duarte, California
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Eligibility: 12 Years to · All · * 1\. Age:
* 16 years old in Module 1 (US only: ≥18year)
* 12 years old in Module 2
2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
* Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
* Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
* Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL
3\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)
4\. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)
5\. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible.
* Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI
6\. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks
NCT05197192Phase 3Recruiting
German CLL Study Group · Helios Klinikum Bad Saarow, Bad Saarow
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).
Eligibility: 18 Years to 120 Years · All · * Documented CLL/SLL requiring treatment according to iwCLL criteria
* Age at least 18 years
* At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.
* Life expectancy ≥ six months
* Adequate bone marrow function indicated by a platelet count \>30 x10\^9/l
* Creatinine clearance ≥ 30ml/min
* Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome
* Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee
* ks prior to registration for study screening (i.e. PCR only required when serology was positive))
* ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2
NCT06111612Phase IIRecruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai General Hospital, Shanghai, Shanghai Municipality
This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d from d -9 to d -8 (2 days), fludarabine at 30mg/m2/d from d -7 to d -3 (5 days), cytarabine at 1-1.5g/m2/d from d -7 to d -3 (5 days), and busulfan at 3.2mg/kg/d from d -5 to d -3 (3 days). Conditioning begins on day -9, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.
Eligibility: 18 Years to 55 Years · All · 1. Age between 18 and less than 55 years, regardless of gender.
2. Criteria for myeloid tumors with extramedullary involvement:
1. AML (Acute Myeloid Leukemia) with at least one extramedullary lesion achieving hematological remission (CR1 or CR2) after induction therapy.
2. MDS (Myelodysplastic Syndrome) with at least one extramedullary lesion and bone marrow blast percentage ≥ 5% achieving hematological CR after treatment; CMML (Chronic Myelomonocytic Leukemia) with at least one extramedullary lesion (diagnosed according to WHO standards) achieving hematological CR after treatment.
3. Control and remission of extramedullary lesions, including those in the central nervous system, testes, skin, and other extramedullary tissues.
4. Granulocytic sarcoma with or without bone marrow involvement, and achieving remission after treatment.
3. Patients must have a suitable hematopoietic stem cell donor:
1. Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
2. Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and
* DRB1.
4. Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.
5. ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.
6. Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
1. Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
2. Cardiac function: Ejection fraction ≥ 50%.
3. Baseline oxygen saturation \> 92%.
4. Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN.
5. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
7. Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
NCT06152809Phase 1Recruiting
Dana-Farber Cancer Institute · Brigham and Women's Hospital, Boston, Massachusetts
The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML) with measurable residual disease or oligoblastic (\< 20% blasts in the bone marrow) disease.
Names of the study therapies involved in this study are:
* Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion
* CIML NK (a cellular therapy)
* IL-2 (a recombinant, human glycoprotein)
* Venetoclax (a selective inhibitor of BCL-2 protein)
Eligibility: 18 Years to · All · Inclusion Criteria for Trial Enrollment (Registration Visit):
* Diagnosis of AML or MDS/AML (10-19% blasts) by 2022 ELN criteria. Historical test results (either peripheral blood or bone marrow) can be used to establish this diagnosis.
* Age ≥ 18 years old
* At time of screening patient has received any prior lines of therapy including prior chemotherapy and any prior stem cell transplant, provided that the stem cell transplant is \> 6 months ago with no ongoing need for immunosuppressive therapy for active graft-versus-host disease.
* Presence of molecular risk factors for relapse as defined by any of the following present at any time during a participant's history of AML:
* 2022 ELN adverse risk karyotype: t(6;9)(p23.3;q34.1)/DEK::NUP214; t(v;11q23.3)/KMT2A-rearranged; t(9;22)(q34.1;q11.2)/BCR::ABL1; t(8;16)(p11.2;p13.3)/KAT6A::CREBBP; inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/ GATA2, MECOM(EVI1), t(3q26.2;v)/MECOM(EVI1)-rearranged; -5 or del(5q); -7; Complex karyotype, monosomal karyotype
* 2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
* Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD
* ECOG performance status ≤2 (see Appendix A)
* Participants must meet the following organ function as defined below:
* Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 x ULN)
* AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
* creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula
* oxygen saturation ≥ 90% on room air
* left ventricular ejection fraction ≥ 40%
* Negative pregnancy test for women of childbearing potential only.
* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after the last IL-2 dose administration.
* Participants with current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
* Subjects must be able to swallow pills.
* No laboratory evidence of ongoing hemolysis in the opinion of investigator (demonstration of hemolysis should include a haptoglobin level that is below assay).
Exclusion Criteria for Trial Enrollment (Registration visit)
* Participants are excluded if they received prior allogeneic stem cell transplant ≤ 6 months ago or require immunosuppressive therapy for active GVHD, received prior donor lymphocyte infusion (DLI) ≤ 2 months ago, or received prior organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy at any time.
* Persisting Grade \> 2 non hematologic toxicity related to prior therapy is excluded; however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
* Autoimmune disease: Patients with a history of inflammatory bowel disease, inc
NCT05780034Phase 1Recruiting
Accutar Biotechnology Inc · Colorado Blood Cancer Institute, Denver, Colorado
This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to:
* Identify the recommended dose of AC676 that can be given safely to participants
* Evaluate the safety profile of AC676
* Evaluate the pharmacokinetics of AC676
* Evaluate the effectiveness of AC676
Eligibility: 18 Years to · All · 1. Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
2. Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).
3. Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.
NCT04440267Phase 2Recruiting
Institute of Hematology & Blood Diseases Hospital, China · HBDH, Tianjin, Tianjin Municipality
In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.
Eligibility: 14 Years to · All · 1. Patients aged above 14 years with acute leukemia of ambiguous lineage .
2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.
3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
5. Patients should sign informed consent form.
NCT05756322Phase 1, Phase 2Recruiting
Lin BioScience, Inc · Moffitt Cancer Center, Tampa, Florida
The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages.
The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.
Eligibility: 18 Years to 120 Years · All · * Male or female subjects greater than 18 years old, inclusive.
* Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL.
* Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
NCT06599762Phase 2Recruiting
University of Manitoba · CancerCare Manitoba, Winnipeg, Manitoba
Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life changing blood cancers. Patients with MDS and AML commonly experience complications related to bleeding, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of tranexamic acid (TXA; a medication that prevents clots from dissolving) to prevent bleeding. In this study, 50% of patients will be randomized (like the flip of a coin) to receive TXA; the other 50% of patients will receive placebo. The investigators will monitor both groups of patients to see if the medication improves the risk and/or severity of bleeding. If tranexamic acid were to safely reduced the frequency of bleeding, this would broadly influence how doctors provide care for patients with MDS and AML around the world.
Eligibility: 18 Years to · All · Master platform inclusion criteria:
1. Age ≥ 18 years
2. Diagnosis of myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm or acute myeloid leukemia
MYELO-CAN TXA inclusion criteria:
1. Receipt of less-intensive chemotherapy (includes both frontline and relapsed/refractory setting)
2. Severe thrombocytopenia (platelets ≤ 30x10\^9/L or platelets ≤ 50x10\^9/L prior to chemotherapy initiation)
NCT03340129Phase 2Recruiting
Melanoma Institute Australia · Westmead Hospital, Sydney, New South Wales
This is a phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.
Eligibility: 18 Years to 120 Years · All · Inclusion Criteria:
1. Female or male patients, ≥18 years of age.
2. Signed, written, informed consent.
3. AJCC Stage IV \[any T, any N, M1d (0) or M1D(1)\] histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary melanoma and at least 1 radiological definitive brain metastasis that is ≥ 5mm and ≤40mm, measurable per RECIST version 1.1 guidelines (modified for brain metastases, enabling up to 5 target lesions in the brain as well as up to 5 extracranial target lesions). There is no upper limit restriction in the number of brain metastases, provided the remaining eligibility criteria are met.
4. The BRAF mutation status must be available prior to randomisation.
5. The treating clinician(s) should consider the intracranial disease amenable to stereotactic radiotherapy over whole brain radiotherapy. Patients for whom there is a definite and immediate indication for radiotherapy (e.g. rapidly progressing disease with associated clinical signs and /or symptoms) should not be considered for enrolment.
6. Brain metastases must be untreated with any modality of radiotherapy or systemic treatment. Previous surgery for melanoma brain metastases is permitted if it resulted in gross total resection and no radiotherapeutic cavity boost was required.
7. No prior systemic treatment for brain metastases is permitted unless given in the neoadjuvant or adjuvant settings for systemic drug the treatment for extracranial disease only. At the time of neoadjuvant or adjuvant systemic therapy for extracranial disease, there should be radiological evidence of the absence of brain metastases. The presenting diagnosis of brain metastases at the time of enrolment in this study must have occurred a minimum of 6 months after stopping neoadjuvant or adjuvant systemic therapy (prior anti PD1, anti PD-L1, anti CTLA-4, BRAF / MEK inhibitors or clinical trial agents) are acceptable in the setting of neoadjuvant or adjuvant treatment
8. Asymptomatic from brain metastases at the time of study enrolment without corticosteroids, analgesia or any other treatment for the management of neurological symptoms (with the exception of antiepileptics prescribed for any reason, provided patient is asymptomatic). Resolved neurological symptoms are permitted if complete resolution, without any intervention, has been sustained for a minimum of 7 days prior to randomisation.
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
10. A life expectancy \> 30 days.
11. Able to undergo MRI with Gadolinium contrast agent. CT of the brain is not an acceptable alternative should patients be unable to safely undergo a contrast MRI.
12. Adequate haematological, hepatic and renal organ function as defined by:
1. White cell count ≥ 2.0 × 10x9/L
2. Neutrophil count ≥ 1.5 × 10x9/L
3. Haemoglobin ≥ 90 g/L
4. Platelet count ≥ 100 x 10x9/L
5. Total bilirubin ≤ 1.5 x ULN
6. Alanine transaminase ≤ 3.0 x ULN
7. Aspartate aminotransferase ≤ 3.0 x ULN
8. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN). If serum creatinine is \> 1.5 x ULN, calculate creatinine clearance using standard Cockcroft-Gault formula. Creatinine clearance must be 40ml/min to be eligible.
13. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first dose of study treatment and agree to use effective contraception from 14 days prior to commencing study treatment, throughout the treatment period and for 23 weeks \* after the last dose of study treatment. Effective contraception includes:
1. Intrauterine device with a documented failure rate of less than 1% per year.
2. Vasectomised partner who is sterile prior to the female partner patient's commencement of study treatment and is the sole sexual partner for that female.
3. Combined (oestrogen and progestogen) hormonal contraception associated with inhibition of ovulation or progestogen only hormonal contraception associa
NCT05824975Phase 1, Phase 2Recruiting
GI Innovation, Inc. · Mayo Clinic in Arizona, Scottsdale, Arizona
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.
Eligibility: 18 Years to · All · Key
* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
* Has adequate organ and marrow function as defined in protocol.
* Measurable disease as per RECIST v1.1.
* ECOG performance status 0-1.
* Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.
* HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.
Key
NCT05867004Phase IIRecruiting
Institut Claudius Regaud · Institut Claudius Regaud, Toulouse
Cutaneous melanoma is a bad prognosis skin cancer, which can be treated with immune checkpoint inhibitors (ICI), such as anti-PD-1 (nivolumab, nivo) and anti-CTLA-4 (ipilimumab, ipi). However, about 50% of patients do not respond or relapse within 3 years post therapy induction, and immune-related adverse events (irAEs), such as colitis, are triggered and can be treated with TNF inhibitor (TNFi; ie, infliximab, inflix). The pharmacodynamic impact of TNFi on the immune and clinical responses remain to be clarified. The investigators previously demonstrated that TNFi enhance the efficacy of ICI in mouse melanoma models. Based on preclinical findings, the investigators implemented two clinical trials in advanced melanoma patients, TICIMEL and MELANFalpha. In TICIMEL, patients are concomitantly treated with TNFi \[certolizumab (certo) or inflix\] and ICI (ipi+nivo). In MELANFalpha, patients are treated with ICI alone. Preliminary results show both tritherapies promote systemic MART-1 specific CD8 T cell responses and that certo but not inflix may improve ICI efficacy and Th1 responses. In mouse melanoma models, TNFi enhance the response to ICI. Investigators' primary objective is to decipher how certolizumab and infliximab influence ICI-dependent anti-tumor immune responses in advanced melanoma patients. The secondary objectives are to analyse the cellular and molecular impact anti-TNF have on ICI-dependent anti-melanoma immune responses and clinical activities (irAEs and efficacy). By combining mouse and human data as well ex vivo functional assays, the investigators will dissect the impact treatments have on anti-melanoma immune responses by flow cytometry and transcriptomic analyses. The investigators expect to clarify (i) the mechanisms by which TNFi enhance ICI efficacy, (ii) identify the best TNFi to be combined with ICI in advanced melanoma patients and (iii) discover TNF-dependent biomarkers of resistance.
Eligibility: 18 Years to · All · * Inclusion in TICIMEL clinical trial (NCT03293784),
* Inclusion in MELANFα trial (NCT03348891)
