Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Study Overview

• Status: Terminated
• Conditions: Melanoma; Renal Cell Carcinoma; Cervical Cancer; Hepatocellular Carcinoma; Gastric Cancer; Ovarian Cancer; Non Small Cell Lung Cancer; Mesothelioma; Bladder Cancer; Triple Negative Breast Cancer; Small-cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Thyroid Cancer; Anal Cancer; Merkel Cell Carcinoma; Biliary Tract Cancer; Microsatellite Instability High; Skin Squamous Cell Carcinoma; Thymic Cancer
• Intervention / Treatment: Drug: Nanrilkefusp alfa; Drug: Pembrolizumab

Detailed Description

This study will assess the safety and tolerability of nanrilkefusp alfa administered as monotherapy and in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary tract cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Czechia
    • Brno, Czechia, Czechia, 65653
      • Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče
• France
  • Marseille, France, 13005
    • Hôpitaux Universitaires de Marseille Timone
  • Paris, France, 75010
    • Hopital Saint Louis
  • Saint-Herblain, France, 44805
    • Institut de cancerologie de l'ouest
  • France
    • Lyon, France, France, 69379
      • Centre Léon Bérard
    • Paris, France, France, 94805
      • Institut Gustave Roussy
    • Toulouse, France, France, 31059
      • Institut Claudius Regaud
• Spain
  • Madrid, Spain, 28050
    • University Hospital Sanchinarro
  • Spain
    • Barcelona, Spain, Spain, 08035
      • Vall d'Hebron Institute of Oncology
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15216
      • University of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
• ECOG performance score 0-1. Patients with ECOG performance score 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion.
• Estimated life expectancy of ≥3 months
• Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy
• At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy.
• Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
• Adequate organ system function
• Negative serum pregnancy test, if woman of child-bearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
• Accessible tumor tissue available for fresh biopsy

Exclusion criteria:

• Untreated central nervous system metastases and/or leptomeningeal carcinomatosis
• Known additional malignancy that is progressing and/or requires active treatment
• Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)
• History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring chronic obstructive pulmonary disease or any chronic inflammatory disease (sarcoidosis etc.)
• Has received a live vaccine within 30 days of planned start of study therapy
• Absolute white blood cell count ≤2.0 ×10e9/L
• Absolute neutrophil count ≤1.0 ×10e9/L
• Platelet count ≤100×10e9/L
• Pregnant or breastfeeding women
• Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy
• Specific co-morbidities

• Parts B and B1:

  • Is hypersensitive to any of the ingredients of pembrolizumab drug product (KEYTRUDA®)
  • History of solid organ transplantation or hematopoietic stem cell transplantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

17

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.25 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.75 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 1.5 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 3 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 6 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 9 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 12 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 15 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 9 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 12 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 1.5 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15; Drug: Pembrolizumab; A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor; Other Names: KEYTRUDA®
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 3 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15; Drug: Pembrolizumab; A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor; Other Names: KEYTRUDA®
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 6 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15; Drug: Pembrolizumab; A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor; Other Names: KEYTRUDA®
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 9 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15; Drug: Pembrolizumab; A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor; Other Names: KEYTRUDA®
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 12 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15; Drug: Pembrolizumab; A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor; Other Names: KEYTRUDA®
Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab), nanrilkefusp alfa 9 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15; Drug: Pembrolizumab; A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor; Other Names: KEYTRUDA®
Experimental: Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D), nanrilkefusp alfa 12 μg/kg; Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.	Drug: Nanrilkefusp alfa; A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15; Other Names: SOT101; SO-C101; RLI-15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)	Grade (gr) 5 not related to disease progression or other causes; Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue <5 days; gr ≥3 correctable electrolyte abnormalities <72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis; Hy's law cases; Gr 3 AST or ALT or gr 3 bilirubinemia >5 days; Hematologic DLTs: gr 4 neutropenia or thrombocytopenia >7 days, febrile neutropenia, gr ≥3 thrombocytopenia with bleeding; Gr 4 immune-related AEs; Gr 3 or 4 non-infectious pneumonitis; Gr 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to gr ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to gr 1 or baseline in 14 days; Gr 2 pneumonitis not downgrading to gr 1 in 3 days; Gr 3 colitis; Part B and Part B1: Recurrent grade 2 pneumonitis	Through Cycle 1 (21 days)
Number of Participants With Adverse Events (AEs)	Nanrilkefusp alfa related only	Day 1 up to approximately 2 years and 2.5 months
Number of Participants With Serious AEs (SAEs)	Nanrilkefusp alfa related only	Day 1 up to approximately 2 years and 2.5 months
Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa	Nanrilkefusp alfa related only	Day 1 up to approximately 2 years and 2.5 months
Number of Participants Who Died	Nanrilkefusp alfa-related deaths only	Day 1 up to approximately 2 years and 2.5 months
Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function)	The following laboratory parameters were assessed: Coagulation: Prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, fibrinogen; Hematology: Hemoglobin, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, platelet count; Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, lipase; Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, white blood cell count, epithelial cells, bacteria; Thyroid function: TSH, free triiodothyronine (T3), free thyroxine (T4); Cardiac function: Cardiac troponin T	Day 1 up to approximately 2 years and 2.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1	This outcome measure presents the overall nanrilkefusp apfa Cmax profile over Cycle 1 Day 1.	Cycle 1 Day 1
Overall Activation Levels of Ki-67+ CD8+ T Cells on Day 6 of Cycle 1	The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD8+ Cells (10^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.	Cycle 1 Day 6
Overall Activation Levels of Ki-67+ CD8+ CD45RO+ CD45RA- T Cells on Day 6 of Cycle 1	The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: Ki-67+ Cells of CD8+ Cells (10^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC; CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (10^9/L) = CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. Absolute count of CD45RO+ CD45RA- (Memory) Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.	Cycle 1 Day 6
Overall Activation Levels of Ki-67+ CD4+ T Cells on Day 6 of Cycle 1	The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD4+ Cells (10^9/L) = Ki-67+ Cells of CD4+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.	Cycle 1 Day 6
Overall Activation Levels of Ki-67+ NK Cells on Day 6 of Cycle 1	The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD3-CD56+ (NK) Cells (10^9/L) = Ki-67+ Cells of CD3-CD56+ (NK) Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.	Cycle 1 Day 6
Overall Activation Levels of Ki-67+ NKT Cells on Day 6 of Cycle 1	The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • CD3+CD56+ (NKT) Cells of CD45+ Live Cells (10^9/L) = CD3+CD56+ (NKT) Cells of CD45+ Live Cells (%) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of Live Cells multiplied by WBC and 0.01.	Cycle 1 Day 6
Overall Activation Levels of Ki-67+ Treg Cells on Day 6 of Cycle 1	The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of Treg Cells (10^9/L) = Ki-67+ Treg Cells (%CD45+) x 0.01 x WBC" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.	Cycle 1 Day 6
Objective Response Rate	Based on investigator review of radiographic images according to Response Evaluation Criteria In Solid Tumors for immune-based therapeutics (iRECIST). Objective response rate according to iRECIST was defined as the percentage of participants with complete response according to iRECIST or partial response according to iRECIST for target lesions and assessed by CT/MRI.	Day 1 up to approximately 5 years 5 months
Duration of Response	Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST for target lesions and assessed by CT/MRI.	Day 1 up to approximately 5 years 5 months
Clinical Benefit Rate	Based on investigator review of radiographic images according to iRECIST. Clinical benefit rate according to iRECIST was defined as the percentage of patients with partial responses, complete responses, and stable disease according to iRECIST for target lesions and assessed by CT/MRI.	Day 1 up to approximately 5 years 5 months
Progression-free Survival	Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death.	Day 1 up to approximately 5 years 5 months
Number of Participants With Anti-drug Antibodies at the End of Treatment		Day 1 until 30 (±2) days after the last dose of nanrilkefusp alfa, up to approximately 5 years 5 months

Collaborators and Investigators

• Sponsor: SOTIO Biotech AG
• Collaborators: SOTIO Biotech a.s.
• Investigators: Principal Investigator: Stephane Champiat, Dr., Institute Gustave Roussy, Villejuif, France

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Non Small Cell Lung Cancer; Gastric Cancer; Melanoma; Cervical Cancer; Ovarian Cancer; Triple Negative Breast Cancer; Microsatellite Instability High; Bladder Cancer; Head and Neck Squamous Cell Carcinoma; Biliary Tract Cancer; Mesothelioma; Renal Cell Carcinoma; Thyroid Cancer; Merkel Cell Carcinoma; Anal Cancer; Small-cell Lung Cancer; Skin Squamous Cell Carcinoma; Thymic Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Infections; Virus Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Biliary Tract Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; DNA Virus Infections; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Adenoma; Neoplasms, Mesothelial; Skin Diseases; Breast Diseases; Lymphatic Diseases; Urologic Neoplasms; Carcinoma; Uterine Cervical Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Uterine Neoplasms; Neuroendocrine Tumors; Tumor Virus Infections; Nevi and Melanomas; Skin Neoplasms; Urinary Bladder Diseases; Carcinoma, Squamous Cell; Thyroid Diseases; Polyomavirus Infections; Carcinoma, Neuroendocrine; Breast Neoplasms; Anus Diseases; Rectal Neoplasms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Squamous Cell Carcinoma of Head and Neck; Stomach Neoplasms; Biliary Tract Neoplasms; Carcinoma, Hepatocellular; Ovarian Neoplasms; Mesothelioma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma; Melanoma; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms; Thymus Neoplasms; Carcinoma, Merkel Cell; Anus Neoplasms; Thyroid Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab
• Other Study ID Numbers: SC103; AURELIO-03 (Other Identifier: SOTIO Biotech AG); 2018-004334-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No