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
Ability to create your own protocols
New Protocol – A Phase 2 Study of Pemigatinib in Patients with Myeloid/Lymphoid Neoplasms with Fibroblast Growth Factor Receptor 1 Rearrangement 8 (FIGHT-203)
Study: Phase 2, open label, multicenter trial Myeloid/Lymphoid Neoplasms 28 patients ≥1 prior therapy Pemigatinib 13.5 mg daily (2 wks; 1 wk off) No prior therapy Pemigatinib 13.5
New Protocol – Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial
Study: Randomised, triple-blind, phase 3 trial Stage IB (tumours of ≥4 cm in diameter), II, or IIIA NSCLC Pembrolizumab 200 mg (590) or placebo (587) / 3 weeks-18 cycles Efficacy:
New Protocol – Avelumab plus axitinib in unresectable or metastatic type B3 thymomas and thymic carcinomas
Study: Single-arm, multicentre, phase 2 trial Had received at least one line of platinum-based chemotherapy Advanced stage thymoma or thymic carcinoma Avelumab 10 mg/kg/14 day and axitinib 5 mg x
New Protocol – Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
Study: Double-blind, placebo-controlled, phase 3 study Untreated unresectable or metastatic biliary tract cancer Gemcitabine – cisplatin plus Durvalumab (341) or placebo (344) Efficacy: 24 month OS: 24.9% vs. 10.4% ORR:
New Protocol – Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
Study: Double-blind, placebo-controlled, phase 3 study Untreated unresectable or metastatic biliary tract cancer Gemcitabine – cisplatin plus Durvalumab (341) or placebo (344) Efficacy: 24 month OS: 24.9% vs. 10.4% ORR:
New Drug – Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer
Study: Open-label phase 1–2 trial Previously platinum-based chemotherapy Advanced or metastatic RET fusion positive NSCLC pts who had been treated with platinum (phase I: 49 pts) and who were untreated
New Drug – Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer
Study: Open-label phase 1–2 trial Previously platinum-based chemotherapy Advanced or metastatic RET fusion positive NSCLC pts who had been treated with platinum (phase I: 49 pts) and who were untreated
New Protocol: Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone with Minimal Residual Disease Response-Adapted Therapy in Newly Diagnosed Multiple Myeloma
Study: Multicenter, single-arm, phase II trial Newly diagnosed multiple myeloma (N:123) High-risk cytogenetic abnormalities: 0:56 1:46 2:24 patients Daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRd) plus AHCT, and Dara-KRd consolidation Efficacy:
New Protocol: Smart Start: Rituximab, Lenalidomide, and Ibrutinib in Patients With Newly Diagnosed Large B-Cell Lymphoma
Study: Open-label, single-center, phase II study Previously untreated non-GCB DLBCL 60 patients Rituximab 375 mg/m2 (D1), lenalidomide 25 mg D(1-10), and ibrutinib 560 mg continuously (RLI) after two cycles, 6
New Indication: Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA)
Study: Open-label, multicentre, phase 3 study Untreated CLL or SLL Patients without del (17) (p13·1) zanubrutinib (group A; n=241) or bendamustine–rituximab (group B; n=238) and patients with del(17) (p13·1)
New Indication: Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312)
Study: Open-label, randomised, phase 3 trial Previously untreated advanced hepatocellular carcinoma Cabozantinib 40 mg plus atezolizumab 1200 mg IV every 3 weeks (N:432), sorafenib 400 mg twice Daily (n:217), or
New Indication: Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312)
Study: Open-label, randomised, phase 3 trial Previously untreated advanced hepatocellular carcinoma Cabozantinib 40 mg plus atezolizumab 1200 mg IV every 3 weeks (N:432), sorafenib 400 mg twice Daily (n:217), or
New Reference: Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer
Study: Phase 3, randomized, double-blind, international trial Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer Pembrolizumab (200 mg every 3 weeks) plus chemotherapy (n:566) or chemotherapy (n:281) Efficacy:
New Reference: Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer
Study: Phase 3, randomized, double-blind, international trial Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer Pembrolizumab (200 mg every 3 weeks) plus chemotherapy (n:566) or chemotherapy (n:281) Efficacy:
New Reference: Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin’s Lymphoma
Study: Multicenter, randomized, open-label trial Stage 3 or 4 advanced Hodgkin’s lymphoma A+AVD (n:664) or ABVD (n:670) Efficacy: OS favored A+AVD over ABVD (HR: 0.59; P=0.009) 6 year OS: 93.9%
New Indication: Crizotinib for ALK-positive inflammatory myofibroblastic tumor
Study: Multicenter, single‐arm, open‐label phase 1b study (PROFILE 1013) ALK‐positive advanced malignancies other NSCLC (N:44) Crizotinib 250 mg x 2 /day Efficacy: ORR: 53% (95% CI, 28-77), CR:8/18 and PR:1/18
New Protocol: Enasidenib in older patients with late-stage mutant-IDH2 relapsed/refractory AML
Study: International, multicenter, randomized, open-label, phase 3 trial Age ≥60 years, IDH2 gene mutated, de novo or secondary AML Previously 2 or 3 prior AML- directed therapies Enasidenib 100 mg/day
New Indication: Trastuzumab Deruxtecan in HER2-Low Advanced Breast Cancer
Study: Randomized, two-group, open- label, phase 3 trial HER2- low, unresectable or metastatic breast cancer One or two previous lines of chemotherapy Trastuzumab deruxtecan (N:373) or the physician’s choice of
New Protocol: Darolutamide in Metastatic, Hormone-Sensitive Prostate Cancer
Study: International, multicenter, phase 3 trial (ARASENS) Metastatic, hormone-sensitive prostate cancer Darolutamide (n=651) or placebo (n=654) with androgen-deprivation therapy and docetaxel. Efficacy: Median treatment duration: 41 m vs 16.7 months