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: 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
New Protocol: Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma
Study: • International, randomized, double-blind, phase 3 trial (SHINE) • 65 years of age or older mantle cell lymphoma • Untreated, stage II to IV disease • Ibrutinib (N:261) or
New Indication: Trastuzumab Deruxtecan in HER2-Low Advanced Breast Cancer
Study: Randomized, two-group, open- label, phase 3 trial HER2- low, unresectable or metastatic breast cancer One or two previous lines of chemotherapy Trastuzumab deruxtecan (N:373) or the physician’s choice of
New Protocol: FLOT Versus FLOT/Trastuzumab/Pertuzumab Perioperative Therapy of HER 2–Positive Resectable Esophagogastric Adenocarcinoma
Study: Multicenter, randomized phase II/III trial HER 2–positive, >= clinical tumor 2 or clinical nodal–positive resectable EGA Four pre and postoperative cycles of either FLOT alone (N:41) or combined with
New Drug: Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
Study: International, open-label, phase 3 trial Metastatic CRPC, previously treated with at least one androgen-receptor-pathway inhibitor and one or two taxane regimens 177Lu-PSMA-617 (7.4 GBq every 6 weeks for four
New Protocol: Venetoclax plus 3 + 7 daunorubicin and cytarabine chemotherapy as first-line treatment for adults with acute myeloid leukaemia
Study: Two-stage, single-arm, phase 2 trial Previously untreated de novo acute myeloid leukaemia IV daunorubicin (60 mg/m2 on days 1-3), IV cytarabine (100 mg/m2 on days 1-7), and oral venetoclax
New Reference: Pembrolizumab for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer
Study: Randomised, open-label, phase 3 study (KEYNOTE-177) Untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer Pembrolizumab 200 mg every 3 weeks (N:153) or to the investigator’s choice (N:154) Efficacy:
New Reference: Pembrolizumab as adjuvant therapy in completely resected stage IIB or IIC melanoma
Study: Double-blind, randomised, phase 3 study (KEYNOTE-716) Newly diagnosed, completely resected stage IIB or IIC melanoma Pembrolizumab (n=483) or placebo (n=486) Efficacy: RFS @ 20.9 mos: 85% vs. 76% [
New Protocol: Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer
Study: Open-label, randomised, phase 3 study (PEACE-1) De novo metastatic prostate adenocarcinoma Standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m2 once every 3 weeks, N:296),