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 Indication: Darolutamide Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16)
Study: Randomized , phase 2 trial Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane Darolutamide (n=92) Efficacy: 12 weeks rPFS:
New indication: Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer (ANCHOR)
Study: Single-arm, multicenter, Phase-2 trial Previosly untreated, BRAF V600E mutant CRC Encorafenib + Binimetinib + Cetuximab q28 (n=95) Efficacy: ORR: 47.4% [37.0-57.9] mPFS: 5.8 mos [4.6-6.6 mos] mOS: 18.3 mos
New Indication: Pembrolizumab as adjuvant therapy for completely resected stage IB–IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091)
Study: Randomized, triple-blind, phase III trial Completely resected, pathologically confirmed stage IB (tumours of ≥4 cm in diameter), II, or IIIA Pembrolizumab (n=590) vs PBO (n=587) Efficacy: mDFS: 53.6 vs.
New Indication: Tucatinib with trastuzumab for colorectal cancer (MOUNTAİNEER)
Study: Phase II, open-label, multicenter study Pretreated, HER2-positive, RAS wild-type, unresectable or metastatic colorectal cancer Tucatinib + Trastuzumab q21 (n=117) Efficacy: ORR: 38% [28-49] DoR: 12.4 mos [8.5-20.5] Safety: Any
New Indication: Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy for Patients with High-Grade Upper Tract Urothelial Carcinoma
Study: Multicenter, single-arm, phase II trial Localized high-grade UTUC or radiographically visible invasive disease Four cycles of split-dose GC (n=57) Efficacy: Pathologic response rate: 63% (37 of 57 pts) Complete
New Indication: Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia (ALPINE)
Study: Phase III, randomized, open-label study Relapsed or refractory CLL/SLL Zanubritinib (n=327) vs. İbrutinib (n=325) Efficacy: 24 mos PFS: 78.4% vs. 65.9% mPFS: NR vs. 34.2 mos, HR:0.65, p=0.002 ORR:
New Indication: Enasidenib in older patients with late-stage mutant-IDH2 relapsed/refractory AML
Study: Phase III, randomized, open-label study Patients aged ≥60 years with late-stage, mutant-IDH2 acute myeloid leukemia (AML) relapsed/refractory (R/R) to 2 or 3 prior AML-directed therapies Enasidenib (n=158) vs. CCR
New Indication: Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma (HIMALAYA)
Study: Open-label, phase 3 trial Unresectable hepatocellular carcinoma and no previous systemic treatment Tremelimumab (300 mg, one dose) plus durvalumab (1500 mg every 4 weeks; STRIDE, n=393), durvalumab (1500 mg
New Indication: Teclistamab in Relapsed or Refractory Multiple Myeloma
Study: Single-arm, multi-cohort, open-label, multicenter, phase 1/2 study Relapsed or refractory myeloma after at least three therapy lines (n=165) Teclistamab sc weekly Efficacy: ORR: 63% [55.2-70.4], CR: 39.4% mDOR: 18.4
New Indication: Cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer (EMPOWER-Lung-3)
Study: Double-blind, placebo-controlled, phase 3 study Untreated advanced or metastatic NSCLC Group A (Cemiplimab + chemotherapy (n=312)) vs. group B (chemotherapy alone (n=154)) Efficacy: mOS : 21.9 vs. 13.0 mos
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 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%