Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials

The Lancet Oncology

Volumn 19, Issue 3, 2018, Pages 416-426

  D'Angelo, Sandra P ^a,b   Mahoney, Michelle R ^c   Van Tine, Brian A ^d   Atkins, James ^e   Milhem, Mohammed M ^f   Jahagirdar, Balkrishna N ^g,h   Antonescu, Cristina R ^a   Horvath, Elise ^i,j   Tap, William D ^a,b   Schwartz, Gary K ^k   Streicher, Howard ^l  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

^c MAYO CLINIC   (United States)

^d WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Novant Health GWSM   (United States)

^f UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

^g REGIONS HOSPITAL   (United States)

^h UNIVERSITY OF MINNESOTA   (United States)

ⁱ Astellas   (United States)

^j UNIVERSITY OF CHICAGO   (United States)

^k Columbia University School of Medicine/Herbert Irving Cancer Center ^*  (United States)

^l NATIONAL CANCER INSTITUTE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATININE; IPILIMUMAB; NIVOLUMAB; ANTINEOPLASTIC AGENT; IMMUNOLOGICAL ANTINEOPLASTIC AGENT;

ADRENAL INSUFFICIENCY; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALGORITHM; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BENIGN NEOPLASM; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; ELECTROCORTICOGRAPHY; FATIGUE; FEMALE; FEVER; FOLLOW UP; HUMAN; HYPONATREMIA; HYPOTENSION; HYPOTHYROIDISM; LEIOMYOSARCOMA; LIPOSARCOMA; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MALIGNANT FIBROUS HISTIOCYTOMA; METASTATIC SARCOMA; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OPEN STUDY; OSTEOSARCOMA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY FAILURE; SARCOMA; SIDE EFFECT; SPINDLE CELL SARCOMA; TIME TO TREATMENT; TREATMENT DURATION; UNITED STATES; URINARY TRACT INFECTION; URINARY TRACT OBSTRUCTION; CLINICAL TRIAL; IMMUNOLOGY; MIDDLE AGED; MORTALITY; PATHOLOGY; SECONDARY; SOFT TISSUE TUMOR; TIME FACTOR; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; FEMALE; HUMANS; IPILIMUMAB; MALE; MIDDLE AGED; NIVOLUMAB; SARCOMA; SOFT TISSUE NEOPLASMS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

EID: 85040678385     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(18)30006-8     Document Type: Article

References (31)

1. Siegel, RL, Miller, KD, Jemal, A, Cancer statistics, 2016. CA Cancer J Clin 66 (2016), 7–30.
2. Seddon, B, Strauss, SJ, Whelan, J, et al. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. Lancet Oncol 18 (2017), 1397–1410.
3. Demetri, GD, von Mehren, M, Jones, RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol 34 (2016), 786–793.
4. Schöffski, P, Chawla, S, Maki, RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet 387 (2016), 1629–1637.
5. van der Graaf, WT, Blay, JY, Chawla, SP, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 379 (2012), 1879–1886.
6. Tap, WD, Jones, RL, Van Tine, BA, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet 388 (2016), 488–497.
7. Hammers, H, Plimack, ER, Infante, JR, et al. Phase I study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma. Ann Oncol 25:suppl (2014), iv361–iv362 (abstr).
8. Rosenberg, JE, Hoffman-Censits, J, Powles, T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet 387 (2016), 1909–1920.
9. Weber, JS, D'Angelo, SP, Minor, D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 16 (2015), 375–384.
10. Wolchok, JD, Kluger, H, Callahan, MK, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 369 (2013), 122–133.
11. Heery, CR, O'Sullivan-Coyne, G, Madan, RA, et al. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol 18 (2017), 587–598.
12. Herbst, RS, Baas, P, Kim, DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 387 (2016), 1540–1550.
13. Hodi, FS, O'Day, SJ, McDermott, DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363 (2010), 711–723.
14. Pardoll, DM, The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 12 (2012), 252–264.
15. D'Angelo, SP, Shoushtari, AN, Agaram, NP, et al. Prevalence of tumor-infiltrating lymphocytes and PD-L1 expression in the soft tissue sarcoma microenvironment. Hum Pathol 46 (2015), 357–365.
16. Raj, S, Bui, M, Gonzales, R, Letson, D, Antonia, SJ, Impact of PD-L1 expression on clinical outcomes in subtypes of sarcoma. Ann Oncol, 25(suppl 4), 2014 iv498 (abstract).
17. Kaufman, HL, Russell, J, Hamid, O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol 17 (2016), 1374–1385.
18. Maki, RG, Jungbluth, AA, Gnjatic, S, et al. A pilot study of anti-CTLA4 antibody ipilimumab in patients with synovial sarcoma. Sarcoma, 2013, 2013, 168145.
19. Tawbi, HA, Burgess, MA, Bolejack, V, et al. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol 18 (2017), 1493–1501.
20. Pollack, SM, He, Q, Yearley, JH, et al. T-cell infiltration and clonality correlate with programmed cell death protein 1 and programmed death-ligand 1 expression in patients with soft tissue sarcomas. Cancer 123 (2017), 3291–3304.
21. Curran, MA, Montalvo, W, Yagita, H, Allison, JP, PD-1 and CTLA-4 combination blockade expands infiltrating T cells and reduces regulatory T and myeloid cells within B16 melanoma tumors. Proc Natl Acad Sci U S A 107 (2010), 4275–4280.
22. Hellmann, MD, Rizvi, NA, Goldman, JW, et al. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. Lancet Oncol 18 (2017), 31–41.
23. Pocock, SJ, Simon, R, Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31 (1975), 103–115.
24. Kaplan, EL, Meier, P, Nonparametric-estimation from incomplete observations. J Am Stat Assoc 53 (1958), 457–481.
25. Wolchok, JD, Neyns, B, Linette, G, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol 11 (2010), 155–164.
26. Postow, MA, Chesney, J, Pavlick, AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 372 (2015), 2006–2017.
27. Rizvi, NA, Hellmann, MD, Snyder, A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science 348 (2015), 124–128.
28. Snyder, A, Makarov, V, Merghoub, T, et al. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med 371 (2014), 2189–2199.
29. Tumeh, PC, Harview, CL, Yearley, JH, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 515 (2014), 568–571.
30. Ben-Ami, E, Barysauskas, CM, Solomon, S, et al. Immunotherapy with single agent nivolumab for advanced leiomyosarcoma of the uterus: results of a phase 2 study. Cancer 123 (2017), 3285–3290.
31. Simon, R, Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10 (1989), 1–10.