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Found 4 Presentations For Request "attend"
1084MO - Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial
- Anna M. Di Giacomo (Siena, Italy)
Abstract
Background
The phase III NIBIT-M2 study showed a 41% 5-year overall survival (OS) of melanoma patients (pts) with asymptomatic brain metastases (BM) treated with ipilimumab (I) plus nivolumab (N) (I+N) (
Methods
The NIBIT-M2 study recruited melanoma pts with active, untreated, asymptomatic BM from 9 Italian Centers that were randomized (1:1:1) to fotemustine (F) (Arm A), I+F (Arm B), or I+N (Arm C). Primary endpoint was OS; among secondary endpoints were intracranial progression-free survival (iPFS) and HRQoL. PROs were assessed at week (W) 1 and W12 using the EORTC Quality of Life Questionnaire (QLQ)-C30 Version 3.
Results
From Jan 2013 to Sept 2018 , 80 pts were enrolled: 76 received F (23), I+F (26), or I+N (27). As of May 1, 2023, at a median follow-up of 67 months (mo), median OS was 8.5 (95% CI: 6.6-10.3), 8.2 (95% CI: 2.1-14.3) and 29.2 (95% CI: 0-69.9) mo for Arm A, B, and C respectively. The 7-y OS rate was 10.0% (95% CI: 0-22.5) in Arm A, 10.3% (95% CI: 0-22.6) in Arm B, and 42.8% (95% CI: 23.4-62.2) in Arm C. Median iPFS was 3.0 (95% CI: 2.3-3.6), 3.3 (95%CI: 1.2-5.4) and 8.7 (95% CI: 0-19.9) for Arm A, B, and C, respectively. The 7-year iPFS rate was 4.3% (95% CI: 0-12.7) in Arm A, 7.7% (95% CI: 0-17.9) in Arm B, and 28.6% (95% CI: 11.2-46.0) in Arm C. Seventy-two pts (compliance 95%) and 34 pts (compliance 45%) completed the baseline and the W12 QLQ C-30 assessment. HRQoL was preserved in all treatment arms; no significant differences were observed in global health score. Most functional scales evaluated were preserved from baseline to W12, with a lower mean score decrease in pts receiving I+N.
Conclusions
The 7-year results of the NIBIT-M2 study, with the longest follow-up available to date in melanoma pts with asymptomatic BM treated with I+N, continue to show persistent therapeutic efficacy. HRQoL was preserved in all treatment arms and I+N induced a lower decrease in mean functional scales.
Clinical trial identification
NCT02460068.
Legal entity responsible for the study
NIBIT Foundation ONLUS.
Funding
Bristol Myers Squibb.
Disclosure
A.M. Di Giacomo: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, MSD, Pierre Fabre, Novartis; Financial Interests, Personal, Invited Speaker: Sanofi. V. Chiarion Sileni: Financial Interests, Personal, Advisory Board, analysis of treatment modality (diagnosis, stanging, surgery, radiotherapy, systemic therapy for Merkel cell carcinoma in Italy: Merck-Serono; Financial Interests, Institutional, Invited Speaker, Treatment option for BRAF mutated melanoma: Novartis; Financial Interests, Institutional, Invited Speaker, Treatment choices for BRAF mutated melanoma, evidence-based, and biologically supported: Pierre Fabre; Financial Interests, Institutional, Invited Speaker, Immunotherapy for melanoma treatment present and future: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, registration, and accommodation to attend ASCO annual meetings: Pierre Fabre. M. Del Vecchio: Financial Interests, Personal, Advisory Board: BMS, MSD, Sanofi, Pierre Fabre, Novartis. P.F. Ferrucci: Financial Interests, Personal, Advisory Board: BMS, Roche, Pierre Fabre, MSD, Novartis. M. Guida: Financial Interests, Personal, Advisory Board: Bristol Meyer Squibb, Novartis, Merck Sharp & Dohme. P. Quaglino: Non-Financial Interests, Personal, Advisory Board: BMS, Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre, MSD. M. Guidoboni: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre; Financial Interests, Personal, Research Grant: Merck Sharp & Dohme. P. Marchetti: Other, Personal, Advisory Board: BMS, Roche, MSD, Novartis, AstraZeneca, Pfizer; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Novartis, Pfizer, Merck Sharp & Dohme, AstraZeneca, Boehringer Ingelheim, Celgene, Roche. A. Covre: Other, Personal, Advisory Board: EpiGen Therapeutics srl. R. Camerini: Financial Interests, Personal, Advisory Board: Bristol Meyer Squibb; Other, Personal, Advisory Board: Reithera srl, Alfasigma SPA, Cosmo Nbv, EpiGen Therapeutics. L. Calabro: Other, Personal, Advisory Board: BMS, AstraZeneca, MSD, Sanofi, Roche. M. Mandalà: Financial Interests, Personal, Advisory Board: MSD, Novartis, Sanofi, BMS, Pierre Fabre; Financial Interests, Personal, Invited Speaker: Sun Pharma. D. Giannarelli: Financial Interests, Personal, Other, Educational Course in Biostatistics: Amgen; Financial Interests, Personal, Other, Course on GRADE system in Hematology: AstraZeneca. M. Maio: Financial Interests, Personal, Advisory Board: BMS, Roche, GSK, Sanofi, Alfasigma, Amgen, Sciclone, Eli Lilly, MSD, Incyte, Pierre Fabre, AstraZeneca; Financial Interests, Personal, Stocks/Shares: EpiGen, Theravance. All other authors have declared no conflicts of interest.
LBA100 - CUP-ONE trial: A prospective double-blind validation of molecular classifiers in the diagnosis of cancer of unknown primary and clinical outcomes
- Harpreet S. Wasan (London, United Kingdom)
Abstract
Background
Cancer of unknown primary remains a major challenge with poor prognoses, protracted pathways and limitations of site-determination by immunohistochemistry. Gene expression signatures (GEP) show promise as molecular cancer classifiers, but their utility in diagnosis and prognosis warrants study. The CUP-ONE Trial prospectively compared a 92-gene assay GEP versus centralized IHC (C-IHC; 10 markers).
Methods
641 consented patients (36 UK sites; 54 mths) had local pathology & MDT outputs classified as a Reference diagnosis (RD). Tissue was allocated, double-blind, randomized to 3 arms (N): C-IHC (329); CTID (418) CancerTYPE ID, Biotheranostics & Healthscope (418; became unviable). Outputs mandated classification to 14 cancer types. The Intention to diagnose (ITD N=392) set had at least 1 available classifier output. Primary Endpoint was %match of a classifier to RD-site of origin (ratio: total number Match results and total number in ITD dataset with a confirmed or suspected RD (C/S; N=131)). Secondary endpoints included overall classifier accuracy in evaluables with a C/S site of origin, concordance of classifiers & a pre-specified diagnostic score.
Results
Investigators final classifications (N) were CUP (451), ‘Suspected’ (72) and revised 118 to ‘known’ sites. In the ITD set: median 67yrs, 50% male, 92% stage IV. 418 (65%) samples were sufficient for 1 classifier output. Sample inadequacy (C-IHC 7.3%; CTID 13.4%) lead to 306 C-IHC & 362 CTID classifications. In Pair-wise comparisons CTID correctly classified 17.2% [1.9%-29.6%; p=0.0243] more than C-IHC; Agreement of 2 classifiers was 97%. Secondary analysis comparisons showed point estimates favouring CTID but not all statistically significant. Both classified Lung, Colorectal, Breast and Ovary well but CTID did particularly well with Cholangiocarcinoma /gall bladder (60% accuracy) but not in pancreas (9.1%) versus C-HIC (27.2%). Median OS (mths) was poor across all 3 groups CUP: 5.3 (4.6-6.4); Suspected: 9.0 (8.3-11.9); Confirmed: 7.8 (5-13).
Conclusions
CUP-ONE assessed accuracy of CTID Vs C-IHC with comparable outcomes but a higher assignment of Cholangiocarcinoma in CUP. Survival was better in the C/S subset but remains poor overall.
Clinical trial identification
ISRCTN17282276, EudraCT: 2008-000657-35.
Editorial acknowledgement
None
Legal entity responsible for the study
NHS Greater Glasgow & Clyde and University of Glasgow.
Funding
Cancer Research UK (Grant Ref C18607/A7967 and Grant Ref C18607/A7742).
Disclosure
H. Soifer: Financial Interests, Personal, Full or part-time Employment: Biotheranostics. K. Treuner: Financial Interests, Personal, Full or part-time Employment, Employment bu Biotheranostics, a hologic company and stock ownership with company (Hologic): Biotheranostics, A Hologic. Y. Zhang: Financial Interests, Personal, Full or part-time Employment, Employment by Biotheranostics, a Hologic Company and stock ownership with the company (Hologic): Biotheranostics, Hologic. C. Schnabel: Financial Interests, Personal, Full or part-time Employment: Biotheranostics. T.R.J. Evans: Financial Interests, Institutional, Advisory Board, Advisory Board for GI cancers and melanoma (immune checkpoint inhibitors): Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker, Invited speaker - GI cancers, melanoma, immunotherapy: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board, Advisory Boards - GI cancers, melanoma: Roche / Genentech; Financial Interests, Institutional, Invited Speaker, Invited speaker GI cancer, melanoma: Roche / Genentech; Financial Interests, Institutional, Advisory Board, Advisory Board (Lenvatinib): Eisai; Financial Interests, Institutional, Invited Speaker, Speaker's fees (lenvatinib): Eisai; Financial Interests, Institutional, Advisory Board, advisory board: MSD, AstraZeneca, Bayer, Bicycle Therapeutics, Clovis; Financial Interests, Institutional, Invited Speaker, Speaker's fees: MSD, AstraZeneca, Bayer; Financial Interests, Institutional, Advisory Board, Advisory board: Nucana; Financial Interests, Institutional, Invited Speaker, speaker's fees: Nucana; Financial Interests, Institutional, Advisory Board, advisory board; Chair of Scientific Advisory Council (HCC & MIV-818): Medivir; Financial Interests, Institutional, Invited Speaker, speaker's fees (and presentation to potential investors): Medivir; Financial Interests, Personal, Other, Support to attend international conferences: Bristol-Myers Squibb, Roche / Genentech, MSD, Nucana, Bayer, Celgene, Pierre Fabre; Financial Interests, Institutional, Advisory Board, Advisory Board for Upper GI Cancer: Ascelia; Financial Interests, Institutional, Advisory Board, Advisory Board for Oesophageal Cancer: Seagen; Financial Interests, Institutional, Coordinating PI, Educational grant (supply of study agents) for investigator-led study and reimbursement of study costs for commercial studies: AstraZeneca; Financial Interests, Institutional, Local PI, reimbursement of study costs for commercial studies: Astellas, Bayer, Roche, Basilea, Celgene, GSK, Immunocore, Medivir, Starpharma, Novartis, Sapience Therapeutics, MiNa Therapeutics, CytomX, Lilly, Bicycle Therapeutics, Sierra, BeiGene, Pfizer, Johnson & Johnson, UCB, Avacta, Codiak, Nurix, T3P; Financial Interests, Institutional, Coordinating PI, reimbursement of study costs for commercial studies: Adaptimmune, Bristol Myers Squibb, Eisai, MSD, Nucana, Sanofi, iOnctura; Financial Interests, Institutional, Local PI, support for non-commercial investigator-led study: Verastem; Financial Interests, Institutional, Local PI, reimbursement for costs of commercial studies: Boehringer Ingelheim; Financial Interests, Institutional, Local PI, reimbursement of costs of commercial study: Seagen; Non-Financial Interests, Member, Cancer Society Member: American Society of Clinical Oncology, America Association for Cancer Research, British Association for Cancer Research, Association of Cancer Physicians (UK), European Association for Cancer Research, International Liver Cancer Association; Non-Financial Interests, Other, Member of Scientific Advisory Panel: Pancreatic Cancer Research Fund; Non-Financial Interests, Other, Annual Meeting abstracts committee: International Liver Cancer Association; Non-Financial Interests, Institutional, Product Samples, Supply of investigational and licensed compounds for a non-commercial study for which I'm Chief Investigator: AstraZeneca; Other, Editor-in-Chief: British Journal of Cancer; Other, Chair of Independent Data Monitoring Committee for a phase 1 trial - honorarium payable to the employing institution: Genmab; Other, Chair and panel member, Scientific Evaluation Committee: early phase trials (Amgen, Merck, AstraZeneca): Institut National du Cancer (France). K.A. Oien: Non-Financial Interests, Institutional, Other, Research collaborations with partners incl. BioTheranostics, Illumina, Leica, OracleBio & BioClavis with funding incl. from Cancer Research UK, Innovate UK & Medical Research Council: University of Glasgow. All other authors have declared no conflicts of interest.
LBA40 - Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma
- Nicoletta Colombo (Milan, Italy)
Abstract
Background
The standard therapy for advanced/recurrent endometrial cancer includes carboplatin and paclitaxel (CP). Robust biological rationale suggested a synergy between immunotherapy and chemotherapy in this setting.
Methods
AtTEnd is an international academic study in endometrial carcinoma/carcinosarcoma patients (pts) with advanced newly diagnosed or recurrent disease with no prior systemic chemotherapy for recurrence. Pts were randomized (2:1 ratio) to receive either CP chemotherapy and atezolizumab (atezo) or placebo, followed by atezo or placebo until disease progression. The mismatch repair (MMR) status was evaluated centrally. Coprimary endpoints with a hierarchical approach were: progression free survival (PFS) in the deficient MMR (dMMR) population, PFS and overall survival (OS) in all comers.
Results
Five hundred and fifty-one pts were enrolled from Oct 2018 to Jan 2022 in 89 sites across 10 countries (median follow-up 28.3 months). Of the 549 pts included in the intention to treat population, 125 (22.8%) had dMMR tumours and 352 (64.1%) had endometrioid carcinoma; 369 (67.2%) had recurrent disease and 148 (82.2%) of newly diagnosed cases had primary stage IV. In the dMMR population, the addition of atezo showed a significant improved PFS (HR 0.36 95% CI:0.23-0.57; p=0.0005; median PFS: not reached vs. 6.9 months for atezo vs placebo). The superiority in PFS was confirmed in all comers (HR 0.74 95%CI:0.61-0.91; p=0.0219; median PFS: 10.1 months vs 8.9 months for atezo vs placebo). Interim analysis of OS in all comers indicated a trend in favor for atezo, despite 45 (24.3%) placebo patients received immunotherapy as subsequent therapy. Second PFS and duration of response in the dMMR population confirmed the efficacy of atezo. Grade≥3 adverse events occurred in 66.9% and 63.8% of pts in atezo vs placebo arm. Safety profile for CP + atezo was manageable and consistent with expected toxicities.
Conclusions
The addition of atezo to standard CP chemotherapy demonstrated a statistically significant improvement in PFS for pts with advanced/recurrent endometrial carcinomas with a substantial benefit in pts with dMMR carcinomas.
Clinical trial identification
EudraCT 2018-001072-37; NCT03603184.
Legal entity responsible for the study
Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
N. Colombo: Financial Interests, Personal, Advisory Board, Various: Roche, PharmaMar, AstraZeneca, MSD/Merck, Clovis Oncology, GSK, Pfizer, Immunogen, Mersana; Financial Interests, Personal, Invited Speaker, Congress, Symposia, Lectures: AstraZeneca; Financial Interests, Personal, Invited Speaker, Lectures: Novartis; Financial Interests, Personal, Advisory Board, Lectures: Eisai; Financial Interests, Personal, Advisory Board, Advisory role: Nuvation Bio, Pieris; Financial Interests, Personal, Advisory Board, Advisory Role: Onxerna; Financial Interests, Institutional, Research Grant: AstraZeneca, PharmaMar, Roche; Non-Financial Interests, Other, Sterring committee member Clinical Guidelines: ESMO; Non-Financial Interests, Leadership Role, Chair, Scientific Committee: ACTO( Alleanza contro il tumore ovarico). K. Harano: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Takeda; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Chugai, Takeda; Financial Interests, Institutional, Research Grant: Merck, Daiichi Sankyo; Financial Interests, Institutional, Local PI: MSD, Daiichi Sankyo, Takeda; Non-Financial Interests, Principal Investigator: Merck, Chugai. Y. Antill: Financial Interests, Personal, Advisory Board: GSK, Eisai, MSD; Financial Interests, Personal, Advisory Board, Coordinating PI: AstraZeneca. F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK/Tesaro, Clovis, Pfizer, Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Novartis, Roche, Gilead/immunomedics, EISAI, PharmaMar, GenomicHealth, Myriad, Seagen; Financial Interests, Institutional, Invited Speaker: Seagen, Daiichi Sankyo, GSK, AstraZeneca; Financial Interests, Institutional, Advisory Board: Roche, Immunicom; Financial Interests, Institutional, Local PI: Roche, Novartis, Eisai, MSD, Vaccibody, GSK; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Roche, Gilead/Immunomedics, German Breast Group, AGO Research GmbH; Financial Interests, Institutional, Funding: AstraZeneca, Lilly, Seagen. E. Petru: Financial Interests, Personal, Advisory Board, Attendance fees: AstraZeneca, EISAI, Lilly, GSK; Financial Interests, Personal, Invited Speaker, Lecture fees: AstraZeneca, EISAI, Lilly, GSK; Financial Interests, Personal, Advisory Board, Fees: MSD, Novartis, Pharma Mar, Roche, Seagen, Pierre fabre, Daiichi Sankyo, GILEAD; Financial Interests, Personal, Invited Speaker, Fees: MSD, Novartis, Roche, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Local PI, Fees to institution: AstraZeneca; Financial Interests, Institutional, Local PI, Patient Fees: Roche; Financial Interests, Institutional, Local PI, Fees: Daiichi Sankyo, Lilly, GSK, Novartis; Financial Interests, Institutional, Local PI, FEES: Seagen, Pierre Fabre. C. Lai: Non-Financial Interests, Personal, Coordinating PI, President: TGOG; Financial Interests, Personal, Full or part-time Employment: CGMH; Non-Financial Interests, Personal, Affiliate, Past President: TGOG. L. Fariñas Madrid: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Institutional, Invited Speaker: AstraZeneca&MSD; Financial Interests, Personal, Invited Speaker: EISAI, GSK. Y.C. Lee: Financial Interests, Institutional, Invited Speaker, Educational events: AstraZeneca; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Institutional, Research Grant: BeiGene. C. Zamagni: Financial Interests, Personal, Advisory Board: Roche, EISAI, Novartis, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Exact Sciences, MSD, GSK, Gilead, Seagen; Financial Interests, Institutional, Local PI: Roche, Novartis, AstraZeneca, Pfizer, Seagen, Medivation, AbbVie, Array BioPharma, Morphotek, Synthon, Daiichi-Sankyo, MSD, GSK, Gilead; Financial Interests, Personal, Other, Member of an Independent Data Monitoring Committee for an international clinical trial: AstraZeneca; Non-Financial Interests, Other, member of the Scientific Committee: LOTO Onlus, Susan J Komen Emilia-Romagna, Mamazone Sudtirol; Other, travel accomodation and partecipation expenses for scientific congresses: Roche, Novartis, Pfizer, Daiichi Sankyo, MSD, GSK, Gilead, AstraZeneca. G. Tasca: Financial Interests, Advisory Board: GSK, AstraZeneca, MSD; Financial Interests, Steering Committee Member: GSK; Financial Interests, Speaker’s Bureau: GSK, AstraZeneca; Financial Interests, Other, Travel Expenses: PharmaMar. M.P. Barretina Ginesta: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, MSD, EISAI, PharmaMar; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, MSD; Financial Interests, Personal, Steering Committee Member: MSD. All other authors have declared no conflicts of interest.
LBA45 - Overall survival (OS) outcomes from NRG-GY004, a phase III study comparing single-agent olaparib or combination cediranib and olaparib to platinum (Plat) based chemotherapy in recurrent plat sensitive ovarian cancer (OvCa)
- Joyce F. Liu (Boston, United States of America)
Abstract
Background
In the NRG-GY004 (NCT02446600) primary analysis, neither olaparib (O) nor combined cediranib and olaparib (C+O) improved progression-free survival (PFS) compared to standard of care (SOC) plat therapy as treatment for relapsed plat sensitive ovca, although median PFS was longer in patients with gBRCAm (Liu et al., J Clin Oncol 2022). We now report the prespecified OS analysis.
Methods
Pts with plat sensitive high-grade serous or endometrioid, or BRCA-related, ovca were randomized 1:1:1 to SOC (carboplatin/paclitaxel; carboplatin/gemcitabine; or carboplatin/liposomal doxorubicin), O (300mg twice daily), or C+O (C 30mg daily + O 200mg twice daily), stratified by gBRCA status, PFI (6-12 vs >12 months), and prior anti-angiogenic therapy. OS was a secondary endpoint; analysis was specified to occur when at least 265 events had occurred cumulatively in the SOC and C+O arms.
Results
Between 4FEB2016 and 13NOV2017, 565 pts enrolled (187 SOC, 189 O, 189 C+O), and 528 pts initiated treatment (166 SOC, 183 O, 179 C+O). 23.7% of patients had gBRCAmt. Median follow-up was 66.5 months; 419 deaths had occurred. The hazard ratio (HR) for OS was 1.27 (95% CI 0.99-1.62, p = 0.06) between O and SOC and 1.12 (95% CI 0.87-1.43, p = 0.38) between C+O and SOC, with median OS of 32.7, 31.0, and 33.5 months for SOC, O, and C+O, respectively. In gBRCA pts, HR for OS was 1.39 (95% CI 0.80-2.42) for O vs SOC and 1.24 (95% CI 0.94-1.63) for C+O vs SOC, with median OS of 43.2, 41.3, and 44.8 mos for SOC, O, and C+O. In non-gBRCA pts, HR for these comparisons was 1.26 (95% CI 0.71-2.21) and 1.07 (0.82-1.40). 46 pts on SOC had non-protocol therapy before disease progression, including 36 pts receiving PARPi. 27.3% of pts on SOC, 7.9% on O, and 10.6% on C+O terminated OS follow-up early prior to death.
Conclusions
In NRG-GY004, neither O nor C+O improved OS compared to SOC as treatment for relapsed plat sensitive ovca. Hazard ratios for OS for both O and C+O exceeded 1 with wide 95% CIs that included 1. These findings must be interpreted with caution given the proportion of pts terminating follow-up early and the number of pts on the SOC arm who received off-protocol PARPi maintenance.
Clinical trial identification
NCT02446600.
Legal entity responsible for the study
National Cancer Institute.
Funding
National Cancer Institute.
Disclosure
J.F. Liu: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, Eisai, Genentech/Roche, GSK, Regeneron Pharmaceuticals, Zentalis; Financial Interests, Personal, Other, Consulting: Bristol-Myers Squibb; Financial Interests, Institutional, Local PI: 2X Oncology, Aravive, Arch Oncology, CytoMX Therapeutics, GSK, Impact Therapeutics, Regeneron, Zentalis; Financial Interests, Institutional, Principal Investigator: AstraZeneca, Bristol-Myers Squibb, Clovis Oncology. U.A. Matulonis: Financial Interests, Personal, Advisory Board: Agenus, AstraZeneca, Blueprint Medicines, Immunogen, Allarity, Boehringer Ingelheim, CureLab, GSK, Merck, NextCure, Novartis, Ovarian Cancer Research Alliance, Trillium; Financial Interests, Personal, Other, DSMB: Alkermes, Symphogen. E. Swisher: Financial Interests, Personal, Advisory Board: Ideaya; Financial Interests, Personal, Other, DSMB: Novartis; Financial Interests, Institutional, Other, Clinical trial support: GSK, Clovis Oncology, Plexxicon. N. Cloven: Financial Interests, Personal, Advisory Board: Toray Industries, GSK, Tarveda, Kartos, Zentalis, Umoja. C. Muller: Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Institutional, Research Funding: AstraZeneca, Genmab, VBL Therapeutics, Roche/Genentech, TapImmune, Linnaeus Therapeutics, Agenus, Incyte, Merck. R. Moore: Financial Interests, Personal, Other, Consulting: Fujirebio Diagnostics; Financial Interests, Personal, Research Funding: Angle plc. K. Fujiwara: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Takeda; Financial Interests, Personal, Advisory Board: MSD, Eisai, Genmab, Nano Carrier, Daiichi Sankyo, Seagen; Financial Interests, Personal, Other, Travel Expense: Clovis; Financial Interests, Institutional, Funding: Regenerone; Financial Interests, Institutional, Research Grant: MSD, Ono, Zeria, Genmab; Financial Interests, Personal and Institutional, Coordinating PI: AstraZeneca; Non-Financial Interests, Leadership Role: GOTIC. A.A. Secord: Financial Interests, Institutional, Local PI: AbbVie, Aravive, AstraZeneca, Clovis Oncology, Eisai, Ellipses Pharma, GSK, I-MAB Biopharma, Immunogen, Merck, OncoQuest, Roche/Genentech, Seagen Inc, VBL Therapeutics, National Cancer Trial Network; Non-Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, Gilead, Immunogen, Imvax, Merck, Mersana, Natera, Onconova, OncoQuest; Non-Financial Interests, Personal, Steering Committee Member, AXLerate trial: Aravive; Non-Financial Interests, Personal, Steering Committee Member, AtTEnd trial: Hoffman-LaRoche; Non-Financial Interests, Personal, Steering Committee Member, OVAL trial: VBL Therapeutics; Non-Financial Interests, Personal, Steering Committee Member, FLORA-5 trial, QPT-ORE-004: CanariaBio. All other authors have declared no conflicts of interest.