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 Indication: Nivolumab + ipilimumab for first-line unresectable malignant pleural mesothelioma
Study: Open-label, randomized phase III trial (CheckMate 743) Previously untreated unresectable MPM Nivolumab + ipilimumab x 2 yrs (n=303) vs. platinum + pemetrexed x 6 cycles (n=302) Efficacy: ORR: 40%
New Protocol: Trifluridine/tipiracil with bevacizumab in chemo-refractory metastatic colorectal cancer
Study: Open-label, randomized phase II trial Metastatic colorectal cancer, refractory or intolerant to fluoropyrimidines, irinotecan, oxaliplatin, and anti-EGFR (for RAS WT) Trifluridine/tipiracil with (n=47) vs. without bevacizumab (n=46) Efficacy: Disease
New Drug: Tepotinib for NSCLC with MET Exon14 skipping mutations
Study: Open-label phase II trial (VISION) Locally advanced or metastatic NSCLC with MET exon 14 skipping mutations (N=99) Efficacy: ORR: 46% [36%-57%] Median DoR: 11.1 mos [7.2 mos – NE]
New Protocol: Trastuzumab deruxtecan for her2-positive gastric cancer
Study: Open-label, randomized phase II trial (DESTINY-Gastric01) Her2-positive gastric/GE junction adenoCa pts who received >=2 previous regimens including 5-FU, platinum, and trastuzumab Trastuzumab deruxtecan (n= 125) vs. physician’s choice of
New Protocol: subQ daratumumab + CyBorD in light chain amyloidosis
Study: Open-label, randomized phase III trial (ANDROMEDA) Newly diagnosed light chain amyloidosis with >=1 affected organ CyBorD with or without subQ daratumumab (n= 195 and 193, respectively) Efficacy: Hematologic CR:
New Protocol: Irinotecan – cetuximab + vemurafenib in bRAF-mutated colorectal cancer
Study: Open-label, randomized phase II trial Metastatic or unresectable colorectal cancer with bRAF-V600E mutation. Received one or more systemic therapy before Irinotecan – cetuximab + placebo (n=50) vs. Irinotecan –
New Indication: Larotrectinib for TRK + Sarcomas
Study: Analysis of three separate clinical trials Adult pts with sarcomas harboring NTRK gene fusions N = 25 => 19 soft tissue sarcoma (STS) – 4 GIST – 2 bone
New Indication: Osimertinib as adjuvant therapy for EGFR-mutated NSCLC
Study: Double-blind, phase 3 trial (ADAURA) Completely resected, non-squamous, stage IB, II, or IIIA; EGFR mutation-positive Osimertinib (n=339) vs. placebo (n=343) Efficacy: DFS @ 2 yrs: 89% vs. 52% (HR:
New Protocol: Selinexor – bortezomib – dexamethasone for previously treated myeloma
Study: Open-label, phase 3 trial (BOSTON) Multiple myeloma progressed on or after last treatment regimen, previously received 1-3 regimens Selinexor – wkly bortezomib – dexamethasone (n=195) vs. twice wkly bortezomib
New Drug: Oral relugolix for androgen-deprivation therapy in advanced prostate cancer
Study: Open-label, phase 3 trial Candidates for >=1 yr of continuous androgen-deprivation therapy Oral Relugolix (n=622) vs. leuprolide (n=308) Efficacy: Sustained testosterone suppression: 96.7% vs. 88.8% (non-inferior) Probability of castration
New Drug: Margetuximab for her2-positive metastatic breast cancer
Study: Phase 3 trial (SOPHIA) in pts with disease progression after >=2 lines of anti-her2 therapy Chemotherapy with margetuximab (n=266) vs. trastuzumab (n=270) Efficacy: ORR: 22% vs. 16% Median PFS:
New Protocol: Hyper-CVAD and sequential Blinatumomab in newly diagnosed Ph-negative ALL
Study: Phase II trial – Newly diagnosed Ph-negative ALL in pts 14-59 yrs (n=39) Hyper-CVAD (with riTUXimab or ofatumumab for CD20 + disease) x 4 cycles followed by 4 cycles
New Protocol: Venetoclax Added to Cladribine + Cytarabine alternating with Azacytidine for newly diagnosed AML in Elderly
Study: Phase II trial – Newly diagnosed AML (excluding APL, CBF) in pts >= 60 yrs Induction with Cladribine + low-dose subQ cytarabine x 1-2 cycles + Venetoclax Consolidation with
New Reference: Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer
Study: Open-label phase 3 trial Previously untreated metastatic MSI-H-dMMR colorectal cancer Pembrolizumab 200 mg q21 (n=153) vs. investigator’s choice of chemo (n=154) Chemo: mFOLFOX6 or FOLFIRI alone or with bevacizumab
New protocol: SubQ daratumumab + pomalidomide + dexamethasone for relapsed/refractory multiple myeloma
Study: Open-label phase 3 trial. Relapsed/refractory MM patients who received >=1 prior line of therapy Daratumumab subQ (1800 mg q1-2 wk) + Pomalidomide + dexamethasone (n=151) vs. Pd alone (n=153)
New Indication: Pralsetinib for advanced RET-mutated thyroid cancer
Study: Phase I/II, single arm (ARROW trial) Advanced RET mutation-positive RAI-refractory thyroid cancer (n=9, all had papillary thyroid cancer) Efficacy: ORR: 89% (52% – 100%), all PR Duration of response
New Indication: Pralsetinib for advanced RET-mutated medullary thyroid cancer
Study: Phase I/II, single arm (ARROW trial) Advanced RET mutation-positive medullary thyroid cancer (MTC, n= 79). Previously treated with cabozantinib or vandetanib or both (n=55) Efficacy: ORR: 65% (overall, 53%-75%),
New Drug: Naxitamab for neuroblastoma
Study: Open label, single arm (Study 201) Refractory or relapsed high-risk neuroblastoma in the bone or bone marrow with a documented partial response, minor response, or stable disease to prior
New Protocol: Pembrolizumab + chemotherapy for previously untreated advanced triple-negative breast cancer
Study: Placebo controlled phase 3 trial Previously untreated locally recurrent inoperable or metastatic triple negative breast cancer Pembrolizumab + chemo (n=566) vs. Placebo + chemo (n=281) Chemo: Weekly PACLitaxel or