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 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 Indication: Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma
Study: Phase 2, confirmatory, multicenter, nonrandomized study Resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma Cemiplimab 350 mg/21 day (four doses) before surgery (N:79) Efficacy: pCR: 40 (51%)
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 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 Reference: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma
Study: Phase 3, open label, randomized study (RELEVANCE) Untreated grade 1-3a FL R2 (n:513) or R-chemo (n:517), followed by rituximab maintenance Efficacy: ORR: 61% and 65%, CR/CRu: 48% and 53%
New Reference: Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor
Study: Randomized, open-label, international, multicenter phase III study Advanced GIST who progressed on or were intolerant to first-line treatment with imatinib Ripretinib 150 mg (n = 226) or sunitinib 50
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 Indication: Dabrafenib and trametinib for unresectable or metastatic solid tumors
Study: Open-label, nonrandomized, phase II basket study Unresectable or metastatic 36 anaplastic thyroid cancer patients Dabrafenib 150 mg x 2 /day plus trametinib 2 mg/day Efficacy: ORR: 56% (95% CI,
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 Reference: Nivolumab plus cabozantinib in first-line treatment for advanced renal cell carcinoma
Study: Open-label, randomised, phase 3 trial (CheckMate 9ER) Previously untreated advanced or metastatic clear-cell renal cell carcinoma Nivolumab 240 mg/2 weeks plus cabozantinib 40 mg/day (N:323) or sunitinib 50 mg/day,
New Indication: Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer
Study: Open-label, phase 3 trial Stage IB to IIIA resectable NSCLC Three cycles neoadjuvant treatment Nivolumab plus platinum-based chemotherapy (N:176) or platinum-based chemotherapy (N:176) Efficacy: mEFS: 31.6 m vs 20.8