Altai Protocol Library
1041 protocols and counting
All protocols with references and links
All protocols reviewed by a Medical Oncologist/Hematologist
All protocols in major guidelines included
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New Protocol: Niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer
Study: Double-blind, placebo-controlled phase 3 trial (MAGNITUDE) Previously untreated, CRPC Abirateron acetate + Niraparib (n=212) vs. Abiraterone acetate + PBO (n=211) Efficacy: BRCAm mrPFS: 16.6 vs. 10.9 mos, HR:0.45, p=0.0003
New Drug: Talquetamab-tgvs for relapsed or refractory multiple
Study: Multicenter, open-label, single-arm trial Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and
New Drug: Pralsetinib for non-small cell lung cancer with RET gene fusions
Study: Multicenter, open-label, multicohort phase 1/2 trial Locally advanced or metastatic RET fusion-positive NSCLC Pralsetinib (n=237) Efficacy: ORR:78% [68-85] mDoR: 13.4 mos [9.4-23.1] Safety: Grade≥ 3: Neutropenia (19%), hypertension (11l%),
New Protocol: First-line regorafenib with nivolumab and chemotherapy in advanced esophageal, gastric, or gastro-esophageal junction cancer
Study: Single-arm, single-center, phase 2 trial Previously untreated advanced oesophageal, gastric, or gastro-oesophageal junction cancer Nivolumab + FOLFOX + Regofenib (n=35) Efficacy: mOS: NR 12 mos OS: 85% [74-98] mPFS:
New Protocol: Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer
Study: Prospective, multicenter, double-blinded, randomized phase 3 study Previously untreated metastatic pancreatic adenocarcinoma Nimotuzumab + Gemcitabine (n=41) vs. Gemcitabine (n=41) Efficacy: mOS: 10.9 vs 8.5 mos, HR:0.66, p=0.080 mPFS: 4.2
New Protocol: Abiraterone Acetate With or Without Cabazitaxel in the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study: Phase II, noncomparative, randomized study Previosly untreated mCRPC Cabazitaxel + AAP (n=42) vs. AAP (n=39) Efficacy: rPFS: 14.8 vs. 6.4 mos mOS: 24.5 vs. 18.3 mos Safety: Grade≥ 3:
New Indication: Perioperative Chemoimmunotherapy With Durvalumab for Muscle-Invasive Urothelial Carcinoma
Study: Phase II, open-label, single-arm study Cisplatin-fit resectable cT2-T4a,cN0-N1 MIUC GC+ Durvalumab followed by surgery followed by Durvalumab maintenance Efficacy: 2-year EFS: 76% [62-85] 3-year EFS: 73% [59-83] 2-year OS:
New Protocol: Tisotumab Vedotin in Combination with Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer
Study: Phase Ib/II, open-label, multicenter study Recurrent or stage IV cervical cancer Arm D: Tisotumab vedotin + Carboplatin (first line, n=33); Arm E: Tisotumab + Pembrolizumab (first line, n=33); Arm
New Drug: Glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas
Study: Phase I-II, open-label, multicenter study Relapse or refractory large cell lymphoma Glofitamab (n=132) Efficacy: cORR: 56% [74 of 132 pts] CR: 43% [ 56 of 132 pts] mDoR: 18.4
New Indication: Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer (MBC)
Study: Phase II, double-blind, placebo-controlled trial (MAINTAIN) Patients with HR+, HER2- MBC, whose cancer progressed during ET and CDK4/6i ET+ Ribociclib (n=60) vs. ET (n=59) Efficacy: mPFS: 5.29 vs. 2.76
New Reference: Pembrolizumab in relapsed or refractory primary mediastinal large B-cell lymphoma
Study: Phase II, open-label, multicenter, multicohort study The patient had to have experienced relapse or be ineligible for ASCT Pembrolizumab (n=53) Efficacy: cORR: 41.5% [22 of 53 pts] CR: 20.8%
New İndication: Trastuzumab deruxtecan in patients with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after trastuzumab-containing regimen
Study: Single-arm, multicenter, phase II trial HER2 positive, unresectable or metastatic gastric or gastro-esophageal junction cancer, progressive disease on or after first-line therapy with a trastuzumab-containing regimen Trastuzumab-deruxtecan (n=79) Efficacy:
New Indication: Pembrolizumab in patients with rare and ultra-rare sarcomas (AcSé)
Study: Single-arm, phase II, basket, multicohort study Sarcomas with an incidence of less than one case per 1.000.000 people per year Pembrolizumab (n=97) Efficacy: Chordoma: ORR: 83% [16 of 34
New Indication: Pembrolizumab plus Lenvatinib as first-line therapy for advanced non-clear-cell renal cell carcinoma
Study: Single-arm, open-label, multicenter, phase II trial Previously untreated stage IV non-clear cell renal cell carcinoma Pembrolizumab + Lenvatinib (n=158) Efficacy: cORR: 49% [78 of 158 pts] CR: 6% [
New Protocol: Olaparib and Temozolomide for Advanced Uterine Leiomyosarcoma (uLMS)
Study: Single-arm, open-label, multicenter, phase II trial Patients with uLMS, progression on ≥1 prior line treatment Temozolomide + Olaparib (n=22) Efficacy: cORR: 27.0% [6 of 22 pts] mPFS: 6.9 mos
New Indication: Avelumab as Second-Line Treatment in Patients with Metastatic Colorectal Cancer and Microsatellite Instability
Study: A Phase II, Randomized, Open-label, multicenter trial Progression under first-line treatment (except for immunotherapy) of dMMR/MSI metastatic colorectal cancer Avelumab (n=65) vs SOC (n=67) Efficacy: mOS: 25.8 vs. 23.4
New İndication: Perioperative Nivolumab and Chemotherapy in Stage III Non–Small-Cell Lung Cancer
Study: A Phase II , Randomized, Open-label , multicenter trial Resectable, stage IIIA or IIIB NSCLC Arm A: Nivolumab + Carboplatin + PaclitaxelS->Nivolumab (n=57) Arm B: Carboplatin + Paclitaxel S->PBO
New Indication: Perioperative Pembrolizumab for Early-Stage Non–Small-Cell Lung Cancer
Study: A Phase III placebo-controlled, Randomized, Open-label trial (KEYNOTE-671) Resectable, early stage (stage II and III) NSCLC Arm A: Pembrolizumab + chemotherapyS->Pembrolizumab (n=397) Arm B: ChemotherapyS->PBO (n=400) Efficacy: mEFS: NR
New Reference: Mirvetuximab soravtansine in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression
Study: A Phase III, Randomized, Open-label trial (MIRASOL) Platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression Mirvetuximab soravtansine (n=227) vs SOC (n=226)