Study of SO-C101 and SO-C101 in Combination With Pembro 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 SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Study Overview

• Status: Active, not recruiting
• 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; Anal Cancer; Merkel Cell Carcinoma; Biliary Tract Cancer; Microsatellite Instability High; Skin Squamous Cell Carcinoma; Thymic Cancer
• Intervention / Treatment: Drug: SO-C101; Drug: pembrolizumab

Detailed Description

This study will assess the safety and tolerability of SO-C101 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 track cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Richard Kapsa; Phone Number: (+420) 2241 74448; Email: kapsa@sotio.com

Study Locations

• Czechia
  • Brno, Czechia, 65653
    • Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče
• France
  • Lyon, France, 69379
    • Centre Leon Berard
  • Marseille, France, 13005
    • Hôpitaux Universitaires de Marseille Timone
  • Paris, France, 75010
    • Hôpital Saint Louis
  • Paris, France, 94805
    • Institut Gustave Roussy
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest
  • Toulouse, France, 31059
    • Institut Claudius Regaud
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Institute of Oncology
  • Madrid, Spain, 28050
    • University Hospital Sanchinarro
• 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: 16 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 is 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 (WOCBP; non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
• Accessible tumor tissue available for fresh biopsy

Exclusion Criteria:

• Key exclusion criteria (Part A and B)

  • Patient with untreated CNS metastases and/or leptomeningeal carcinomatosis (see list of all exclusion criteria for details)
  • 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 COPD or any chronic inflammatory disease (sarcoidosis etc.)
  • Has received a live vaccine within 30 days of planned start of study therapy (see list of all exclusion criteria for details)
  • Absolute WBC count ≤ 2.0 ×109/L;
  • ALC ≤0.5×109/L
  • Absolute neutrophil count ≤1.0 ×109/L
  • Platelet count ≤100×109/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 (see list of all exclusion criteria for details)
  • Specific co-morbidities (see list of all exclusion criteria for details)
  • Is hypersensitive to any of the ingredients of pembrolizumab drug product (KeytrudaTM)
  • 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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Part A (SO-C101 Monotherapy); Drug: SO-C101	Drug: SO-C101; SO-C101; Other Names: SOT101
Experimental: Experimental: Part B (SO-C101 combined with pembrolizumab); Drug: SO-C101 Drug: pembrolizumab	Drug: SO-C101; SO-C101; Other Names: SOT101; Drug: pembrolizumab; pembrolizumab
Experimental: Experimental: Part A1 (SO-C101 divided dosing, Monotherapy); Drug: SO-C101, twice a day as 2 divided doses (50%:50%)	Drug: SO-C101; SO-C101; Other Names: SOT101
Experimental: Experimental: Part B1 (SO-C101 divided dosing, combined with pembrolizumab); Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Drug: pembrolizumab	Drug: SO-C101; SO-C101; Other Names: SOT101; Drug: pembrolizumab; pembrolizumab
Experimental: Experimental: Part D (SO-C101 Monotherapy, dose expansion at the RP2D identified in Part A); Drug: SO-C101 Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, and relapsed/refractory advanced/metastatic melanoma.	Drug: SO-C101; SO-C101; Other Names: SOT101
Experimental: Part D1 (SO-C101 divided dosing, Monotherapy, dose expansion at RP2D identified in Part A1); Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, and relapsed/refractory advanced/metastatic melanoma.	Drug: SO-C101; SO-C101; Other Names: SOT101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A;Number of Participants With Dose-Limiting Toxicities (DLT):	DLT was defined as any of the following AEs occurring in the first cycle of treatment which were attributable to the study drug: •Grade 5 events not clearly related to disease progression or any other causes, grade 3 or higher non-hematologic toxicity regardless of duration, and Hy's law cases will be considered DLTs. .•Grade 3 AST, ALT, or bilirubinemia that lasts >5 days •Grade 4 neutropenia or thrombocytopenia lasting >7 days; Febrile neutropenia; Grade 3 or higher thrombocytopenia with bleeding; Grade 4 immune-related AEs regardless of duration; Grade 3 or grade 4 non-infectious pneumonitis regardless of duration; Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, that do not downgrade to grade ≤2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids or downgrade to grade 1 or baseline within 14 days; Grade 2 pneumonitis that does not resolve to grade 1 within 3 days of care; Grade 3 colitis	Through Cycle 1 (a cycle is 21 days]
Part A;Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.	Cycle 1, Day 1 (each cycle is 21 days) through study completion an average of 1 year
Part A;Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pre-treatment state	assessed in average of 7 months
Part A;Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed	assessed in average of 7 months
Part A;Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology	Laboratory parameters included hematological and biochemistry includes Na, Cl, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine, glucose (preferably fasting) for hyper- or hypoglycemia, urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, and lipase, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets and white blood cells Hematology panel will include hemoglobin, glycated hemoglobin HbA1c at study entry, hematocrit, red blood cell count (for anemia), reticulocytes, WBC count (with full differentiation for leukopenia, neutropenia and etc)), ALC (lymphopenia), and platelet count assessment of for thrombocytopenia.	Cycle 1 Day 1 (each cycle is 21 days) through study completion, an average of 1 year
Part A;Number of Participants With Laboratory Test Abnormalities: Urinalysis	Urinalysis parameter includes: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, WBC, epithelial cells, bacteria. In case of proteinuria ≥100 mg/dL at screening, a 24-hour urine analysis will have to be performed (prior to the start of SO-C101 treatment) to document 24-hour proteinuria levels and a urine test will continue during the treatment period. In case of increase of proteinuria with ≥300 mg/dL (at any time), a 24-hour urine analysis will be performed. Test abnormalities was defined as deviation from normal range: Urine blood/hemoglobin abnormality was defined as presence and absence of blood/hemoglobin in urine of participants	Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year
Part A;Number of Participants With Clinically Significant Change From Screening in Vital Signs	Vital signs included blood pressure, pulse rate, respiratory rate and weight. Change from screening values which are considered to be clinically significant based on investigator's judgement	Screening, through study completion, an average of 1 year
Part A; Number of Participants With Eastern Cooperative Oncology Group [ECOG] Performance Status Score	ECOG performance status was used to assess how disease affect the daily living abilities of a participant. It was measured on a scale ranging from 0 to 4, where 0=fully active (able to carry on all pre-disease activities without restriction); 1=restricted in physically strenuous activity but ambulatory (able to carry out light/sedentary work); 2=ambulatory and capable of all self-care but unable to carry out any work activities (for more than 50% of waking hours); 3=capable of limited self-care, confined to bed or chair (for >50% of waking hours); 4=completely disabled, not capable of any self-care, totally confined to bed or chair. Higher scores signified =more functional impairment of a participant.	Screening, through study completion, an average of 1 year
Part B: Number of Participants With Dose-Limiting Toxicities (DLT): Dose Finding Phase	DLT was defined as any of the following AEs occurring in the first cycle of treatment which were attributable to the study drug: •Grade 5 events not clearly related to disease progression or any other causes, grade 3 or higher non-hematologic toxicity regardless of duration, and Hy's law cases will be considered DLTs. .•Grade 3 AST, ALT, or bilirubinemia that lasts >5 days •Grade 4 neutropenia or thrombocytopenia lasting >7 days; Febrile neutropenia; Grade 3 or higher thrombocytopenia with bleeding; Grade 4 immune-related AEs regardless of duration; Grade 3 or grade 4 non-infectious pneumonitis regardless of duration; Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, that do not downgrade to grade ≤2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids or downgrade to grade 1 or baseline within 14 days; Grade 2 pneumonitis that does not resolve to grade 1 within 3 days of care; Grade 3 colitis	Cycle 1 Day 1 to Cycle 2 Day 1 21 days
Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pre-treatment state	Cycle 1 Day 1, up to 90 days after last dose of study drug (assessed in average of 7 months
Part B: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pre-treatment state	Cycle 1 Day 1, up to 90 days after last dose of study drug (assessed in average of 7 months
Part B: Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed.	Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year
Part B: Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology	Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters includes Na, Cl, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine, glucose (preferably fasting) for hyper- or hypoglycemia, urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, and lipase, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets and white blood cells Hematology panel includes hemoglobin, glycated hemoglobin HbA1c at study entry, hematocrit, red blood cell count (for anemia), reticulocytes, WBC count (with full differentiation for leukopenia, neutropenia and etc)), ALC (lymphopenia), and platelet count assessment of for thrombocytopenia.	Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year
Part B: Number of Participants With Laboratory Test Abnormalities: Urinalysis	Urinalysis parameter includes: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, WBC, epithelial cells, bacteria. In case of proteinuria ≥100 mg/dL at screening, a 24-hour urine analysis will have to be performed (prior to the start of SO-C101 treatment) to document 24-hour proteinuria levels and a urine test will continue during the treatment period. In case of increase of proteinuria with ≥300 mg/dL (at any time), a 24-hour urine analysis will be performed. Test abnormalities was defined as deviation from normal range: Urine blood/hemoglobin abnormality was defined as presence and absence of blood/hemoglobin in urine of participants	Screening, through study completion, an average of 1 year
Part B: Number of Participants With Clinically Significant Change From Screening in Vital Signs	Vital signs included blood pressure, pulse rate, respiratory rate and weight. Change from screening values which are considered to be clinically significant based on investigator's judgement.	Screening, through study completion, an average of 1 year
Part B: Number of Participants With Eastern Cooperative Oncology Group [ECOG]	ECOG performance status was used to assess how disease affect the daily living abilities of a participant. It was measured on a scale ranging from 0 to 4, where 0=fully active (able to carry on all pre-disease activities without restriction); 1=restricted in physically strenuous activity but ambulatory (able to carry out light/sedentary work); 2=ambulatory and capable of all self-care but unable to carry out any work activities (for more than 50% of waking hours); 3=capable of limited self-care, confined to bed or chair (for >50% of waking hours); 4=completely disabled, not capable of any self-care, totally confined to bed or chair. Higher scores signified =more functional impairment of a participant.	Screening, through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A PK parameters	Assess plasma concentration of SO-C101 at various timepoints	assessed in average of 2 months
Part A Objective response rate (ORR)	based on investigator review of radiographic images according to iRECIST	assessed in average of 5 months
Part A Best overall response (BOR)	BOR by iRECIST	assessed in average of 5 months
Part A Duration of Response (DOR)	DOR by iRECIST	assessed in average of 5 months
Part A Clinical benefit rate (CBR)	CBR by iRECIST	assessed in average of 5 months
Part A Progression-Free Survival (PFS)	PFS by iRECIST	assessed in average of 5 months
Part A Immunogenicity analysis to assess antibodies to SO-C101 in human serum	to assess antibodies to SO-C101 in human serum	assessed in average of 4 months
Part B PK parameters of SO-C101 administered in combination with pemrolizumab	Assess plasma concentration of SO-C101 (administered in combination with pembrolizumab) at various timepoints	assessed in average of 2 months
Part B Objective response rate (ORR)	SO-C101combined with pemrolizumab based on investigator review of radiographic images according to iRECIST	assessed in average of 5 months
Part B Best overall response (BOR) of SO-C101	combined with pemrolizumab by iRECIST	assessed in average of 5 months
Part B Duration of Response (DOR)	of SO-C101 combined with pembrolizumab by iRECIST	assessed in average of 5 months
Part B Clinical benefit rate (CBR)	of SO-C101 combined with by iRECIST	assessed in average of 5 months
Part B Progression-Free Survival (PFS)	of SO-C101combined with pemrolizumab by iRECIST	assessed in average of 5 months
Immunogenicity analysis to assess antibodies to SO-C101	SO-C101 in human serum	assessed in average of 4 months

Collaborators and Investigators

• Sponsor: SOTIO Biotech AG
• Collaborators: SOTIO Biotech a.s.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 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 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

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

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