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: Selinexor/pomalidomide/dexamethasone for relapsed/refractory multiple myeloma
Study: Part of open-label Phase I/IIb STOMP – dose escalation and expansion phases MM with >= 3 prior lines of therapy (to include PI and IMiD) Selinexor (SEL) and pomalidomide New Protocol: Selinexor/daratumumab/dexamethasone for relapsed/refractory multiple myeloma
Study: Part of open-label Phase I/IIb STOMP – dose escalation and expansion phases MM with >= 3 prior lines of therapy (to include PI and IMiD) Selinexor: Once wkly 100
New Reference: Cemiplimab for first-line treatment of advanced non-small-cell lung cancer (PD-L1 >=50%)
Study: Phase III, open-label (EMPOWER-Lung 1) Advanced NSCLC with PD-L1 >=50%. Never-smokers excluded Cemiplimab 350 q21 (n=283) vs. platinum doublet (n=280). Crossover from chemo to cemiplimab allowed Efficacy: ORR: 39%
New Reference: Enfortumab vedotin for previously treated advanced urothelial carcinoma
Study: Randomized, open label phase III trial (EV-301) Locally advanved/metastatic urothelial carcinoma, received platinum and progressed during/after PD-1/PD-L1 inhibitor Enfortumab vedotin (n=301) vs. chemotherapy (DOCEtaxel, PACLitaxel, vinflunine; n=307) Efficacy: CR/ORR:
New Drug: Umbralisib for relapsed/refractory follicular and marginal zone lymphoma
Study: Open-label phase II trial (UNITY-NHL), Umbralisib 800 mg PO daily Relapsed/refractory disease, non-transplant candidates, had received anti-CD20 Marginal zone (n=69, MZL), Follicular (n=117, FL, non-grade IIIB) Efficacy: CR/ORR: 16%/49%
New Indication: Lenvatinib + Pembrolizumab for advanced renal cell carcinoma
Study: Randomized phase III trial (CLEAR) Advanced renal cell carcinoma with no previous therapy Lenvatinib (LEN) + pembrolizumab (PEM) (n=355) vs. lenvatinib + everolimus (EVE) (n=357) vs. sunitinib (SUN) (n=357)
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