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: Atezolizumab for early-stage NSCLC
Study: Open-label Phase III trial (IMpower010) Completely resected early-stage NSCLC s/p adjuvant platinum-based chemo Atezolizumab 1200 q21 x 1 yr vs. best supportive care Efficacy: Among pts with stage II-IIIA
New Drug: Cabozantinib for differentiated thyroid cancer
Study: Double-blind, randomized Phase III trial (COSMIC-311) RAI-refractory differentiated thyroid cancer pts with prior lenvatinib or sorafenib Cabozantinib 60 mg daily vs. placebo Efficacy: ORR: 18% vs. 0% Median PFS:
New Drug: Tisotumab vedotin for advanced cervical cancer
Study: Open-label, single-arm Phase II trial (innovaTV 204) Recurrent/metastatic squamous cell, adenoCa or adenosquamous cervical cancer, progressed on/after doublet chemo Tisotumab vedotin 2 mg/kg (max 200 mg) q21 (N=102) Efficacy:
New Drug: Mobocertinib for EGFR Exon 20 insertion NSCLC
Study: Open-label Phase I/II trial (EXCLAIM) EGFR EX20ins+ metastatic NSCLC with >=1 prior line of therapy, platinum-pretreated (n=114) Mobocertinib 160 mg PO daily Efficacy: ORR: 28%, Disease control rate: 78%
New Indication: Zanubrutinib for Waldenstrom macroglobulinemia
Study: Randomized, open-label Phase III trial (ASPEN) WM pts requiring treatment at any line Cohort 1: MYD88 L265P mutated pts => zanubrutinib 160 mg BID (n=102) vs. ibrutinib 420 mg
New Indication: Ivosidenib for IDH1 mutant advanced cholangiocarcinoma
Study: Double-blind, randomized Phase III trial (ClarIDHy) Advanced cholangiocarcinoma with IDH1 mutation, progressed after 1 or 2 lines of therapy Ivosidenib 500 mg daily (n=124) vs. placebo (n=61) Efficacy: Median
New Indication: Nivolumab for adjuvant urothelial carcinoma
Study: Double-blind, randomized Phase III trial (CheckMate 274) Pts with muscle-invasive urothelial Ca, s/p R0 resection, with/without neoadjuvant chemo Nivolumab 240 q14 (n=353) vs. placebo (n=356) Efficacy: Median DFS: 20.8
New Indication: Dostarlimab for dMMR solid cancers
Study: Cohort F of phase I GARNET trial Progressed following systemic therapy and dMMR by IHC (mostly GI tract origin) Dostarlimab 500 mg q21 x 4 => 1000 mg q42
New Drug: Belzutifan for cancers associated with von Hippel-Lindau disease
Study: Open label Phase II trial (Study 004) Adults with germline vHL alterations with clear-cell RCC (N=61). Pts had other vHL-associated tumors: 12 pts had measurable pNET, 24 pts had
New Protocol: Pembrolizumab for early triple-negative breast cancer
Study: Placebo controlled, randomized Phase III trial (KEYNOTE-522) Newly diagnosed, non-metastatic (T1cN1-2 or T2-4N0-2), triple-negative breast cancer CARBOplatin-PACLitaxel x 4 => AC/EC x 4 => Surgery => adjuvant Rx: With
New Indication: Avapritinib for Advanced Systemic Mastocytosis
Study: Phase II study with 2 cohorts (PATHFINDER) Advanced systemic mastocytosis Avapritinib 200 mg PO daily (N=32, interim analysis) Efficacy: CRR: 19% ORR: 75% 93% of pts achieved >=50% reduction
New Protocol: Lenvatinib for advanced grade 1/2 pancreatic and GI neuroendocrine tumors
Study: Open-label phase II trial (TALENT) Advanced pancreatic (panNET) or gastrointestinal (GI-NET), grade 1/2 neuroendocrine tumor progressed on a targeted agent (pancreatic) or somatostatic analog (GI) Lenvatinib 24 mg PO
New Protocol: Vemurafenib + riTUXimab for hairy cell leukemia
Study: Phase II single-center trial (HCL-PG03) Refractory or relapsed hairy cell leukemia with b-raf V600E mutation Total of 18 wks of therapy including vemurafenib 960 mg BID x 8 wks
New Indication: Pembrolizumab for her2-positive gastric/GEJ adenoCa
Study: Randomized, double-blind phase III study (KEYNOTE-811) First-line treatment for metastatic her2-positive gastric or GEJ adenocarcinoma Chemotherapy + trastuzumab + pembrolizumab (n=133) vs. chemotherapy + trastuzumab + placebo (n=131) Chemotherapy:
New Indication: Adjuvant nivolumab for esophageal / GEJ cancer
Study: Randomized, double-blind, placebo controlled phase III (CheckMate 577) Resected stage II/III esophageal or gastroesophageal junction cancer (R0) who had received neoadjuvant chemoradiotherapy and NOT achieved pathological CR Adjuvant nivolumab
New Indication: Neoadjuvant FOLFIRINOX for locally advanced rectal cancer
Study: Randomized, open-label phase III (UNICANCER-PRODIGE 23) Newly diagnosed cT3/T4M0 rectal adenoCa Arm A: 6 cycles of FOLFIRINOX => Chemoradiotherapy (50 Gy with capecitabine) => Surgery => Adjuvant chemo (mFOLFOX6
New Drug: Infigratinib for FGFR2+ cholangiocarcinoma
Study: Single-arm phase II study (BGJ398) Advanced/metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements with progression on >= 1 line Infigratinib 125 mg PO daily (21/28 days) Efficacy: ORR: 23.1% [15.6%-32.2%] Median DoR:
New Drug: Amivantamab for EGFR Exon 20 Insertion Mutant NSCLC post-platinum
Study: Single-arm phase II study (CHRYSALIS) Advanced/metastatic NSCLC (EGFR Exon20ins) second-line post-platinum chemo Amivantamab single agent Efficacy: ORR: 36% [25%-47%] Median DoR: 6.8 mos [5.0 mos – NR] Median PFS:
New Drug: Sotorasib for k-ras G12C mutated NSCLC
Study: Single-arm phase II study (CodeBreaK 100, phase II part) Locally advanced or metastatic k-ras G12C mutant non-small cell lung cancer, progressed on anti-PD-1/PD-L1 and/or platinum-based combination chemotherapy AND targeted