Clinical Studies and Scientific Evidence

Conducting Phase II, III, and IV clinical trials across multiple oncology lines, supported by a strong track record in patient recruitment and data quality.

Established Clinical Experience

Track Record of SISA Studies

Full record of international multicenter clinical studies conducted by our team of Principal Investigators.

Phase Title Sponsor
PHASE IIIVIKTORIA-2 Phase 3 study of gedatolisib as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer (VIKTORIA-2)Celcuity Inc
-CAMBRIA-2 D8531C00001 Adjuvant endocrine therapy study of camizestrant (AZD9833) in ER+/HER2- early breast cancerAstraZeneca
-BURAN AN2025H0301 on buparlisib (AN2025) in combination with paclitaxel versus paclitaxel monotherapy, for patients with recurrent or metastatic squamous cell carcinoma of the head and neck.Adlai Nortye Biopharma
-CAPITELLO-292 D361DC00001 Randomized study of capivasertib in patients with locally advanced, unresectable, or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (CAPItello-292)AstraZeneca SA
-CAMBRIA-1 D8531C00002 Study of camizestrant in ER+/HER2- early breast cancer after at least 2 years of standard adjuvant endocrine therapyAstraZeneca
-DESTINY-04 DS8201-A-U306: Trastuzumab deruxtecan for subjects with HER2-positive gastric or gastroesophageal junction adenocarcinoma after progression during or after a trastuzumab regimenDaiichi Sankyo
-J2J-MC-JZLH: A study of Imlunestrant versus standard endocrine therapy in patients with early breast cancerEli Lilly Interamérica Inc Sucursal Argentina
-TROPION Breast02 D926PC00001 Randomized study of Dato-DXd in patients with triple-negative breast cancer (TROPION Breast02)AstraZeneca
PHASE IIIVIKTORIA-1 CELC-G-301 Phase 3 study of gedatolisib in patients with Rh-positive, HER2-negative advanced breast cancer (VIKTORIA-1)PSI CRO SRL
-MO43576 RANDOMIZED MULTICENTER OPEN-LABEL CROSSOVER STUDY TO EVALUATE PARTICIPANT AND HEALTHCARE PROFESSIONAL INFORMED PREFERENCE REGARDING SC ADMINISTRATION OF ATEZOLIZUMAB COMPARED TO IV FORMULATION IN PARTICIPANTS WITH NON-SMALL CELL LUNG CANCERProductos Roche S.A.Q. e I.
PHASE IC4391001 - Phase I/Ib study of PF-07220060 in participants with advanced solid tumorsPfizer SRL
PHASE IIII3Y-MC-JPEF (postMONARCH) Phase III, randomized, double-blind, placebo-controlled study to compare the efficacy of abemaciclib plus fulvestrant with placebo plus fulvestrant in participants with HR+, HER2- advanced or metastatic breast cancer progressing on endocrine therapy and a CDK4/6 inhibitorEli Lilly Interamérica Inc Sucursal Argentina
PHASE IIIJ2J-OX-JZLC: EMBER-3: Phase III, randomized, open-label study of LY3484356 versus investigator's choice endocrine therapy in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer, previously treated with endocrine therapyLilly
-NTRK A study to evaluate the effect of Larotrectinib in adults and children with tumors positive for NTRK gene fusion. In Argentina, only over 18 years old.Bayer
-DESTINY-Breast09 D9670C00001: Study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) with or without pertuzumab compared to taxane, trastuzumab, and pertuzumab as first-line treatment in HER2-positive advanced or metastatic breast cancer.AstraZeneca
-DESTINY-BREAST06 D9770C0001 Study of Trastuzumab Deruxtecan in patients with HER2-low metastatic breast cancer that has progressed on endocrine therapy [DESTINY-BREAST06]AstraZeneca
-Study with Durvalumab for the Treatment of patients with non-small cell lung cancer with Minimal Residual Disease following Surgery and Curative Intent TherapyAstraZeneca
-Study of Durvalumab to evaluate efficacy in the Adjuvant setting combined with chemotherapy for non-small cell lung cancer.AstraZeneca
PHASE IIII3Y-MC-JPCW eMonarcHER: Phase III study of abemaciclib plus standard adjuvant endocrine therapy in participants with high-risk, node-positive, HR+, HER2+ breast cancerLilly
-FLAURA2 Study of osimertinib with or without platinum-based chemotherapy plus pemetrexed, as first-line treatment in locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation (FLAURA2)AstraZeneca
-GSK 209229: Study of GSK3359609 versus placebo in combination with pembrolizumab for the first-line treatment of recurrent/metastatic PD-L1 positive squamous cell carcinoma of the head and neckGlaxoSmithKline
PHASE IIIRandomized, double-blind, phase III study to evaluate the efficacy and safety of capivasertib + paclitaxel versus placebo + paclitaxel as first-line treatment for patients with histologically confirmed, locally advanced (inoperable), or metastatic triple-negative breast cancerAstraZeneca
-Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Non-Small Cell Lung CancerAstraZeneca
PHASE IIICDRB436F2410 Open-label, phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of BRAFV600 mutation-positive stage III melanomaNovartis
PHASE IIIRandomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib, and trametinib versus the combination of placebo, dabrafenib, and trametinib in patients with unresectable or metastatic BRAF V600 mutant melanoma who have not received prior treatmentNovartis
PHASE IIIPHASE 3 STUDY OF ADXS11-001 ADMINISTERED AFTER CHEMORADIATION AS ADJUVANT TREATMENT FOR HIGH-RISK LOCALLY ADVANCED CERVICAL CANCER:Alzeca Biosciences
-SOLAR-1 BYL719C2301 Alpelisib for PIK3CA Mutated, Hormone Receptor Positive Advanced Breast CancerNovartis
PHASE III3Y-MC-JPBZ monarcHER: Phase II, randomized, multicenter, 3-arm, open-label study to evaluate the efficacy of abemaciclib plus trastuzumab with or without fulvestrant compared to physician's choice standard chemotherapy plus trastuzumab in women with advanced breast cancerLilly
-SELECT-1: Efficacy and safety of selumetinib in combination with docetaxel as second-line treatment for locally advanced or metastatic KRAS-positive non-small cell lung cancer (NSCLC) (stage IIIB-IV)AstraZeneca
PHASE IIIMO28048 - MULTINATIONAL, MULTICENTER, OPEN-LABEL, NON-RANDOMIZED, PROSPECTIVE, TWO-COHORT PHASE III STUDY TO EVALUATE THE SAFETY OF SUBCUTANEOUS TRASTUZUMAB WITH ASSISTED ADMINISTRATION AND SELF-ADMINISTRATION AS ADJUVANT TREATMENT IN PATIENTS WITH OPERABLE HER2+ EARLY BREAST CANCER.Roche
-Saruparib (AZD5305) plus camizestrant compared to CDK4/6 inhibitor plus endocrine therapy or plus camizestrant in HR-positive, HER2-negative (IHC 0, 1+, 2+/ISH not amplified) BRCA1, BRCA2, or PALB2m advanced breast cancerAstraZeneca
-Study to evaluate ABP 206 compared to OPDIVO® (Nivolumab) in subjects with unresectable or metastatic melanomaBristol Myers Squibb
PHASE IIIC4391022: INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OLDER THAN 18 YEARS WITH ADVANCED/METASTATIC BREAST CANCERPfizer SRL
-ABP 206: Randomized, double-blind study evaluating the pharmacokinetic similarity of ABP 206 compared to OPDIVO® (nivolumab) in subjects with stage III or stage IV excised melanoma in the adjuvant settingPAREXEL International S.A.
-MB12-C-01-22: Multicenter, multinational, randomized, double-blind study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with stage IV non-squamous non-small cell lung cancerLaboratorio Elea Phoenix S.A
-MB12-C-01-22: Multicenter, multinational, randomized, double-blind study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with stage IV non-squamous non-small cell lung cancerSyneos Health Argentina S.A.
PHASE IICO44194 MULTICENTER RANDOMIZED AND DOUBLE-BLIND PHASE II STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED TO PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH LOCALLY ADVANCED PREVIOUSLY UNTREATED UNRESECTABLE OR METASTATIC PD-L1 POSITIVE TRIPLE-NEGATIVE BREAST CANCERProductos Roche S.A.Q. e I.
PHASE IIIC4891001_Open-Label Phase 3 Study of ARV-471 (PF-07850327) versus Fulvestrant in Participants with ER(+)/HER2 Advanced Breast Cancer (VERITAC-2)Pfizer
PHASE IIIINAVO 122 WO44263 PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF INAVO IN COMB WITH PHESGO VS PLACEBO IN COMB WITH PHESGO AS MAINT THERAPY AFTER 1st LINE INDUC THERAPY IN PARTICIPANTS WITH HER2+, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA MUTATIONRoche
PHASE IIIA PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT PLUS EVEROLIMUS COMPARED WITH PHYSICIAN'S CHOICE OF ENDOCRINE THERAPY PLUS EVEROLIMUS IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCERNovartis Argentina S.A.
PHASE IIIINAVO 121 WO43919- PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB+FULVESTRANT VERSUS ALPELISIB+FULVESTRANT IN PATIENTS WITH HORMONE RECEPTOR+, HER-2 NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA MUTATIONRoche
PHASE IIIINAVO 120 WO41554 - PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INAVO + PALBO AND FULVESTRANT, VERSUS PLACEBO + PALBOCICLIB AND FULVESTRANT IN PATIENTS WITH HER2-, LOCALLY ADVANCED OR METASTATIC BREAST CANCER, WITH POSITIVE HORMONE RECEPTORS AND PIK3CA MUTATION.Roche
PHASE IIIBO42864 RANDOMIZED, OPEN-LABEL, PHASE III STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR FIRST-LINE TREATMENT OF METASTATIC, RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCERRoche
PHASE IIRC48-ADC Phase 2, multi-cohort, open-label, multicenter clinical study to evaluate the efficacy and safety of disitamab vedotin (RC48-ADC) in subjects with locally advanced unresectable or metastatic urothelial carcinoma with HER2 receptor expressionRemeGen Co
PHASE I/IIDZ2019E0001 WU Kong1 Phase I/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy of DZD9008 in patients with advanced non-small cell lung cancer (NSCLC) with EGFR or HER2 mutationDizheng Pharmaceutical
-20210104 - A Study Evaluating Bemarituzumab in Solid Tumors with FGFR2b OverexpressionAmgen
PHASE IIIMO43110 MULTINATIONAL MULTICENTER RANDOMIZED OPEN-LABEL PHASE IIIB STUDY EVALUATING PATIENT PREFERENCE FOR HOME ADMIN OF FIXED-DOSE COMBINATION PERTUZUMAB AND TRASTUZUMAB FOR SC ADMIN IN PARTICIPANTS WITH EARLY STAGE OR LOCALLY ADVANCED/INFLAMMATORY HER2-POSITIVE BREAST CANCERRoche
PHASE IIIHEREDERA WO43571 RANDOMIZED OPEN-LABEL PHASE III STUDY TO EVALUATE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO COMPARED WITH PHESGO AFTER INDUCTION THERAPY WITH PHESGO PLUS TAXANE IN PTS WITH LOCALLY ADVANCED OR METASTATIC HER2+ AND ESTROGEN RECEPTOR+ BREAST CANCER WITHOUT PRIOR TTORoche
PHASE IIWO42312 RANDOMIZED, OPEN-LABEL, MULTICENTER PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF GDC-9545 COMPARED WITH ENDOCRINE MONOTHERAPY IN PATIENTS WITH PREVIOUSLY TREATED, HER2-NEGATIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCERRoche
PHASE IIIYO42137 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF ATEZOLIZUMAB IN COMBINATION WITH TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) OR ALONE, IN PATIENTS WITH UNRESECTABLE ESOPHAGEAL SQUAMOUS CELL CARCINOMA WHOSE CANCERS HAVE NOT PROGRESSED FOLLOWING CHEMORADIOTHERAPYRoche
PHASE IIIJ2G-MC-JZJC: Phase III Study comparing LOXO-292 to platinum- and pemetrexed-based therapy, with or without pembrolizumab (LIBRETTO-431)Lilly
PHASE IIIRANDOMIZED, OPEN-LABEL, MULTICENTER PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT, COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCERNuvisan Pharma
-TCD16210: Study of safety and efficacy of SAR442720 in combination with pembrolizumab in advanced malignanciesSanofi-aventis
-213831: Comparison of efficacy and safety of niraparib with placebo in participants with HER2-negative breast cancer with BRCA mutation or triple-negative breast cancer with molecular disease based on the presence of ctDNAGSK
-AMEERA-5 EFC15935 Amcenestrant (SAR439859) plus palbociclib as first-line treatment for patients with ER(+), HER2(-) advanced breast cancer (AMEERA-5).Sanofi-aventis
-EPIKO CBYL719H12301: Study evaluating the efficacy and safety of alpelisib in combination with nab-paclitaxel in subjects with advanced triple-negative breast cancer with PIK3CA mutation or PTEN loss without PIK3CA mutationNovartis
PHASE IIIWO41994 - MULTICENTER, RANDOMIZED PHASE III STUDY TO EVALUATE EFFICACY AND SAFETY OF ATEZOLIZUMAB WITH CABOZANTINIB VS CABOZANTINIB ALONE, FOR PATIENTS WITH ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH TUMOR PROGRESSIONRoche
PHASE IIIMO39193: MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH EARLY RELAPSING TRIPLE-NEGATIVE BREAST CANCER (METASTATIC OR INOPERABLE LOCALLY ADVANCED)Roche
PHASE IIIBO41843 Multicenter, randomized, double-blind, placebo-controlled phase III study evaluating efficacy and safety of GDC-9545 combined with palbociclib versus letrozol combined with palbociclib in patients with HER2-NEG, estrogen receptor +, locally advanced or metastatic breast CARoche
-213400: Placebo-controlled study comparing niraparib plus pembrolizumab versus placebo and pembrolizumab as maintenance therapyGSK
-EFC15858-CARMEN- SAR408701 versus docetaxel in previously treated patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)-positive metastatic non-squamous non-small cell lung cancerSanofi-aventis
-Compare the effect of capivasertib + fulvestrant relative to placebo + fulvestrant by evaluating PFS in the overall population.AstraZeneca
PHASE IIIRandomized, double-blind, controlled Phase 3 study of Cabozantinib in combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in previously untreated patients with advanced or metastatic renal cell carcinoma of intermediate or poor riskBristol Myers Squibb
PHASE IIACT16105 Phase II study of SAR439859 versus physician's choice of therapy in locally advanced or metastatic ER-positive breast cancer in pre-menopause or post-menopauseSanofi-aventis
PHASE IIICO41101 - RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III STUDY OF IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND PACLITAXEL AS TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED INOPERABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCERRoche
PHASE IIIElacestrant monotherapy, compared with standard of care, in patients with ER+/HER2- advanced breast cancer who have previously received a CDK4/6 inhibitor: A randomized, open-label, active-controlled, multicenter, phase 3 trial (237119)Menarini
PHASE IIPhase 2, single-arm study of bempegaldesleukin (NKTR-214) in combination with nivolumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancerBristol Myers Squibb
PHASE IIIRandomized, open-label, phase 3 study to evaluate enfortumab vedotin compared to chemotherapy in subjects with previously treated locally advanced or metastatic urothelial cancer (EV-301)Astellas
-BO39633: MULTICENTER, OPEN-LABEL, LONG-TERM OBSERVATIONAL AND EXTENSION STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD SPONSORED ATEZOLIZUMAB STUDYRoche
PHASE IIICO40016 - DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED PHASE III STUDY OF IPATASERTIB IN COMBINATION WITH PACLITAXEL AS TREATMENT FOR PATIENTS WITH TRIPLE-NEGATIVE OR HORMONE RECEPTOR-POSITIVE AND HER2-NEGATIVE BREAST CANCER WITH ALTERED PIK3CA/AKT1/PTENRoche
-BO29554: STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENT FOR PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOODRoche
-CBYL719X2402 Study to evaluate the efficacy and safety of alpelisib plus fulvestrant or letrozol, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed during or after treatment with CDK 4/6 inhibitorsNovartis
PHASE IIIRANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF PF-05280014 PLUS PACLITAXEL COMPARED WITH TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCERPfizer
PHASE IIIWO40324 Two-arm, randomized, multicenter, open-label phase III study to evaluate the pharmacokinetics, efficacy, and safety of SC administration of the fixed-dose combination of pertuzumab and trastuzumab in comb. with chemotherapy in patients with early her2+ breast cancerRoche
PHASE IIIMO29872 OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE III STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB COMPARED TO CHEMOTHERAPY IN PATIENTS WITH ADVANCED OR RECURRENT NON-SMALL CELL LUNG CANCER (STAGE IIIB NOT AMENABLE TO MULTIMODAL TREATMENT) OR METARoche
PHASE IIII3Y-MC-JPCF Phase III, randomized, open-label study of abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone in patients with early-stage, high-risk, node-positive breast cancer,Lilly
PHASE IIIB7391003: RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY OF PF-06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE PRIMARY TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCERPfizer
-B9991001: Study of Avelumab in patients with advanced or metastatic urothelial cancer after completing first-line platinum-based chemotherapyPfizer
PHASE IIIEGF114299 Alternative A phase III, randomized study that found dual Her 2 blockade using lapatinib trastuzumab plus Aromatase Inhibitor compared to single Her 2 blockadeGlaxoSmithKline
-EGF117165. Study of biomarkers associated with response to subsequent therapies in patients with HER2-positive metastatic breast cancer treated with trastuzumab combined with lapatinib or chemotherapy.GlaxoSmithKline
PHASE IIIWO29522 - MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH NAB-PACLITAXEL COMPARED TO PLACEBO WITH NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC TRIPLE-NEGATIVE BREAST CANCERRoche
PHASE IIIGlobal, randomized, open-label, multicenter, phase III study of combination therapy of MEDI4736 with Tremelimumab compared to standard treatment with platinum-based chemotherapy in patients receiving first-line treatment for advanced or metastatic lung cancer (NSCLC)AstraZeneca
PHASE IIII5B-MC-JGDJ: Randomized, double-blind, placebo-controlled Phase 3 study with doxorubicin plus olaratumab versus doxorubicin plus placebo in patients with advanced or metastatic soft tissue sarcomaLilly
PHASE III4T-MC-JVDB: Randomized Phase 2 trial evaluating the pharmacokinetics and safety of four dose regimens of ramucirumab in the second-line treatment of gastric or gastroesophageal junction adenocarcinomaLilly
PHASE IIIJUNIPER I3Y-MC-JPBK: Randomized Phase 3 study of abemaciclib plus best supportive care compared to Erlotinib plus best supportive care in patients with stage IV NSCLC with a detectable KRAS mutation who progressed after platinum-based chemotherapyLilly
-MK3475-061 vs Paclitaxel in gastroesophageal adenocarcinoma.MSD
PHASE IIICOMBI-AD (GSK2118436) (GSK1120212): Phase III, randomized, double-blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection.GlaxoSmithKline
PHASE II/IIIBO27952 - A RANDOMIZED, MULTICENTER, ADAPTIVE, PHASE II/III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE (T-DM1) VERSUS TAXANE (DOCETAXEL OR PACLITAXEL) IN PATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE GASTRIC CANCERRoche
-BO22589 - 3-arm, multicenter study to evaluate the efficacy and safety of T-DM1 in combination with pertuzumab or T-DM1 in combination with pertuzumab placebo compared to the combination of trastuzumab plus taxane, as first-line treatment for breast cancerRoche
PHASE IIIEXELISIS XL092-304: Open-label, randomized phase 3 study to evaluate XL092 in combination with nivolumab compared to sunitinib in participants with advanced or metastatic clear cell (non-clear) renal cell carcinoma.Exelisis
-REGENERON 2055 R3767-ONC-2055Regeneron
PHASE IIITROPION 07 DS1062-A-U303: Randomized, phase 3 study of datopotamab deruxtecan (Dato-DXd) and pembrolizumab, with or without platinum chemotherapy, in subjects without prior therapy for non-small cell lung cancerAstraZeneca
-Dato-DXd plus pembrolizumab versus pembrolizumab alone in the first-line treatment of subjects with advanced or metastatic NSCLC without actionable genomic alterationsAstraZeneca
PHASE IIIHARMONY (REGN3767, anti-LAG-3): A Phase 3 study of Fianlimab (REGN3767, anti-LAG-3) + Cemiplimab versus Pembrolizumab, in patients with previously untreated, unresectable, locally advanced or metastatic melanoma.Regeneron
-Savolitinib plus osimertinib versus platinum-based doublet chemotherapy in participants with mutated EGFR and MET overexpression and/or amplification NSCLC who have progressed on osimertinibAstraZeneca
PHASE IIIRandomized, open-label, phase 3 study of tisotumab vedotin compared to investigator's choice chemotherapy in second or third line for recurrent or metastatic cervical cancerEli Lilly Interamérica Inc Sucursal Argentina
-CYCLONE 3 I3Y-MC-JPEG: Study of abemaciclib with abiraterone in men with hormone-sensitive high-risk metastatic prostate cancerEli Lilly Interamérica Inc Sucursal Argentina
Scientific Evidence

International Publications

2026

Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer

P. Schmid, H.L. McArthur, B. Xu, F. Cardoso, M. Casalnuovo

Annals of Oncology
2025

Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer

S.M. Tolaney, Z. Jiang, M. Casalnuovo, S. Loibl, et al.

The New England Journal of Medicine
2024

Imlunestrant with or without Abemaciclib in Advanced Breast Cancer (EMBER-3)

K.L. Jhaveri, P. Neven, M.L. Casalnuovo, F.-C. Bidard, et al.

The New England Journal of Medicine

Frequently Asked Questions

Technical and general information for patients and referring physicians.

What is an oncology clinical trial?

A medical research study in which volunteer patients participate. Its purpose is to evaluate whether a new treatment, such as a drug, targeted therapy, or immunotherapy, is safe and effective, with the goal of improving current standards of cancer care.

Is it safe to participate in a clinical study?

Yes. All protocols are strictly regulated by national health authorities and independent ethics committees. The absolute priority of the medical research team is the patient’s safety and well-being, and participants are monitored continuously.

What do Phases I, II, and III mean in a clinical trial?

Clinical trials are divided into consecutive stages to ensure the safety and effectiveness of treatments:

  • Phase I: The first administration of the drug in humans. Its main objective is to evaluate safety and tolerability, as well as define the appropriate dose for later studies, including the maximum tolerated dose or the recommended dose for Phase II.
  • Phase II: A phase aimed at exploring the treatment’s efficacy in a specific population. Its main objective is to determine whether the drug shows clinical activity while continuing to assess its safety.
  • Phase III: A confirmatory phase whose main objective is to demonstrate that the new treatment is superior, non-inferior, or equivalent to the current standard of care. The results of this phase support regulatory decisions and changes in clinical practice.
How do I know if I am eligible to participate as a patient?

Please consult your oncologist, who can advise you on the criteria established by the study. Each protocol has strict inclusion requirements based on diagnosis, stage, and previous treatments.

Is there any cost to participate?

No. If the patient meets the inclusion criteria and voluntarily decides to join the study, the investigational medication, diagnostic tests such as laboratory work and CT scans, and medical consultations related to the protocol are fully covered by the study sponsor.