Altai Protocol Library
1041 protocols and counting
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All protocols reviewed by a Medical Oncologist/Hematologist
All protocols in major guidelines included
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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),
New Indication: Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma
Study: Phase II-III, multicenter, randomized, double-blind, placebo-controlled study (SEAL) Advanced dedifferentiated liposarcoma who received 2-5 lines chemotherapy Selinexor (N: 188) or placebo (N:97) twice weekly in 6-week cycles Efficacy: No
New Reference: Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia
Study: Double-blind, randomized, placebo-controlled, phase 3 trial Newly diagnosed IDH1-mutated acute myeloid leukemia Ineligible for intensive induction chemotherapy Oral ivosidenib and azacitidine (N:72) or placebo and azacitidine (N:74) Efficacy: HR
New Drug: Pacritinib for Myelofibrosis
Study: International, multicenter, randomized, double-blind trial (PERSIST-2) Intermediate-1, intermediate-2, or high-risk disease myelofibrozis Pacritinib 400 mg (n=75) vs pacritinib 200 mg BID (n=74) vs BAT (n=72 Efficacy: >35% spleen volume
New Protocol: Darolutamide in Metastatic, Hormone-Sensitive Prostate Cancer
Study: International, multicenter, phase 3 trial (ARASENS) Metastatic, hormone-sensitive prostate cancer Darolutamide (n=651) or placebo (n=654) with androgen-deprivation therapy and docetaxel. Efficacy: Median treatment duration: 41 m vs 16.7 months
New Protocol: Pembrolizumab in Early Triple-Negative Breast Cancer
Study: Randomized, double-blind, placebo-controlled trial (KEYNOTE-522) Previously untreated stage II or III triple-negative breast cancer Neoadjuvant/adjuvant pembrolizumab (n=784) or placebo (n=390) plus standard therapy Efficacy: 36-mo-EFS: 84.5% [81.7%-86.9%] vs 76.8%
New Indication: Cemiplimab in Recurrent Cervical Cancer
Study: Open-label, multicenter, phase 3 trial (EMPOWER-Cervical 1) Recurrent or metastatic cervical carcinoma, progressed after prior platinum-containing therapy Cemiplimab (n=304) or single-agent chemotherapy (n=304) Efficacy: mOS: 12.0 mos vs. 8.5
New Indication: Nivolumab Combination in Advanced Esophageal Squamous-Cell Carcinoma
Study: Global, randomized, open-label, phase 3 trial (CheckMate 648) Unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma with no previous systemic therapy for advanced disease Nivolumab plus chemotherapy (n=321) or
New Reference: Paclitaxel and Carboplatin for uterine carcinosarcoma
Study: International, randomized, open label, noninferiority phase III Chemotherapy-naïve uterine or ovarian carcinosarcoma CARBOplatin + PACLitaxel (n=228) or Ifosfamide + PACLitaxel (n=221) for 6-10 cycles Efficacy: For UCS: mOS: 37
New Indication: Trastuzumab, Pertuzumab, and Docetaxel in Advanced her2+ Non–Small-Cell Lung Cancer
Study: Multicenter, nonrandomized phase II study HER2-mutated, advanced NSCLC with ≥ one previous line including platinums Pertuzumab+trastuzumab+docetaxel (n=45) Efficacy: ORR: 29%, SD: 58% mPFS: 6.8 mos, mOS: 17.6 mos 5
New Indication: Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer
Study: Multicenter, international, phase 2 study Metastatic HER2-mutant NSCLC, refractory to standard treatment Trastuzumab deruxtecan (N=91) Efficacy: mPFS: 8.2 mos, mOS:17.8 mos mDOR: 9.3 mos Safety: All patients had adverse
New Drug: Relatlimab and Nivolumab in Advanced Melanoma
Study: Double-blind, randomized Phase II-III trial Untreated metastatic or unresectable melanoma Relatlimab and nivolumab vs nivolumab alone Efficacy: mPFS: 10.1 vs 4.6 mos (HR:0.75; P=0.006) 12 months PFS: 47.7% vs
New Reference: Ribociclib plus Letrozole in Advanced Breast Cancer
Study: Randomized phase III trial (MONALEESA-2) Postmenopausal, HR-positive, HER2-negative recurrent or metastatic breast cancer with no previous systemic therapy for advanced disease Ribociclib or placebo in combination with letrozole Efficacy:
New Reference: DD-MVAC vs. GC in muscle-invasive bladder cancer
Study: Randomized phase II trial (GETUG-AFU V05 VESPER) Nonmetastatic muscle-invasive bladder cancer Dd-MVAC vs gemsitabin+cisplatin. Neoadjuvant OR adjuvant chemotherapy Efficacy: Organ confined response: 77% v 63% (p = 0.001) Neoadjuvant
New Protocol: Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer
Study: Multicenter, randomized controlled trial (PREOPANC) Resectable or borderline resectable pancreatic cancer 3 cycles of gemcitabine combined with RT (n=119) or upfront surgery plus adjuvant 4 cycles gemcitabine (n=127) Efficacy: