NCT03637764 — consolidated Schedule of Activities

usdm_data · 3 tables · 54 activities (0% compression) · 39 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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▼ Main Schedule (10 columns)
ActivityInTable 1
Study Phase
[epoch] L1		Screening (up to 28 days before Day 1)Screening (up to 28 days before Day 1)Treatment Phase1Treatment Phase1Treatment Phase1Treatment Phase1End of Treatment (EOT)Post Treatment Follow-up PhasePost Treatment Follow-up PhasePost Treatment Follow-up Phase
Cycle / Follow-up Period
[period] L2		Screening (up to 28 days before Day 1)Screening (up to 28 days before Day 1)Cycle 1Cycle 1Cycle 1Cycle 2 and BeyondSafety follow-up PeriodSafety follow-up PeriodSurvival follow-up
Study Day / Visit Timing
[study_day] L3		D-28 to D-15D-14 to D-1D1 (±1)D8 (± 1)D15 (±1)D1 (± 2)30 (±7) days after last IMPs adminAt 60 (±7) days after last IMPs adminAt 90 (±7) days after last IMPs adminEvery 90 days (±7) after last safety follow-up
Sample RNT (h) Ref: SOI Atezolizumab
[timepoint] L4
Sample RNT (h) Ref: SOI Isatuximab
[timepoint] L5
Sample time window Atezolizumab
[window]
Sample time window Isatuximab
[window]
Informed consent/ Inclusion and exclusion criteria4T1XX
Demography, Medical/Surgical and Disease HistoryT1XX
Physical examination6T1X (<7days prior to first dose)X3X3XXXX
Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM)6T1XXXX3X3XXXX
Vital Signs7T1XXXX3X3XXXX
Resting O2 saturation for SCCHN7T1XXXX3X3XX
12-Lead ECG8T1XXAs clinically indicatedAs clinically indicated
Laboratory AssessmentsT1
Pregnancy test (WOCBP only)2T1X (within 7 days prior to first dose)XXXX (every 30±7 days until 5 months after last dose of study treatment)
Blood Chemistry9T1XXX3X3XXXX
Hematology10T1XXX3X3XXXX
Coagulation(GBM)10T1XXX3X3XX
Coagulation (for HCC, SCCHN, and EOC)10T1XAs clinically indicatedAs clinically indicated
Blood Typing Interference Test5T1XCycle 2 Day 1 only
Serology HBV and HCV (for HCC only)10T1XX
Urinalysis (at baseline and if required) /urine dipstick10T1XXAs clinically indicatedAs clinically indicatedAs clinically indicatedXXX
Disease AssessmentT1
CT/MRI (for HCC, SCCHN, and EOC)11T1XXX (Weeks 9, 18, 27, and then every 12 weeks)X (if necessary)X (until PD is confirmed if no PD documented & confirmed)X (until PD is confirmed if no PD documented & confirmed)
Brain MRI (for GBM only)11T1X (within 14 days prior to first dose)X (Weeks 6, 12, 18, 24, and then every 9 weeks)X (if necessary)X (until PD is confirmed if no PD documented & confirmed)X (until PD is confirmed if no PD documented & confirmed)
AFP (for HCC) / CA125 (for EOC)11T1XX (Weeks 9, 18, 27, and then every 12 weeks)X (if necessary)X (until PD is confirmed if no PD documented & confirmed)X (until PD is confirmed if no PD documented & confirmed)
Isatuximab AdministrationT1XX3X3X
Atezolizumab AdministrationT1XX
AE/SAE AssessmentT1XXContinuously throughout periodContinuously throughout periodContinuously throughout periodContinuously throughout periodContinuously throughout periodX (ongoing related AEs, ongoing SAEs at EOT and new related AE/SAEs)X (ongoing related AEs, ongoing SAEs at EOT and new related AE/SAEs)X (ongoing related AEs, ongoing SAEs at EOT and new related AE/SAEs)
Prior/Concomitant MedicationT1X (within 14 days prior to first dose)X (within 14 days prior to first dose)Continuously throughout periodContinuously throughout periodContinuously throughout periodContinuously throughout periodContinuously throughout periodX (related to AE/SAEs listed above)X (related to AE/SAEs listed above)X (related to AE/SAEs listed above)
PK12T1
ADA12T1
Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw13T1
Subsequent Anticancer Therapy StatusT1XXXX
Survival StatusT1X
IMP administration (IV infusion)T2
Pharmacokinetics14,22T2
Immunogenicity (ADA)14,18,22T2
Peripheral BloodT3
Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM)T3
Baseline or on treatment tumor biopsy core in order of priority (Biopsy to be performed for HCC, SCCHN, and EOC if adequate archival tissue is not available)T3
▼ Subsidiary Schedule (29 columns)
ActivityInTable 2Table 3
Study Phase
[epoch] L1		Treatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhaseTreatment PhasePost-treatmentPost-treatmentScreeningTreatment Phase24Treatment PhaseTreatment PhaseTreatment PhasePost-Treatment PhasePost-Treatment Phase
Cycle
[cycle] L2		Cycle 1Cycle 1Cycle 1Cycle 1Cycle 1Cycle 1Cycle 1Cycle 1Cycle 1Cycle 2Cycle 2Cycle 2Cycle 3Cycle 3Cycle 4Cycle 4Cycle 4Cycle 4Subsequent CyclesSubsequent CyclesEOTFUP (90±7 days)Cycle 1Cycle 2Cycle 3Cycle 5 and BeyondEOTFollow-up
Day within the Cycle
[study_day] L3		D1D1D1D1D1D1D1D15D15D1D1D1D1D1D1D1D1D1D1D1D-28 to D-1D1 (-1 day)D1D1D130 (±7) days after last IMP admin60 (±7) days after last IMP admin
Sample RNT (h) Ref: SOI Atezolizumab
[timepoint] L4		SOIEOIEOI +30 min------SOI--SOI-SOI---SOI---
Sample RNT (h) Ref: SOI Isatuximab
[timepoint] L5		SOI--EOIEOI +4h72h168h (SOI of Day 8)SOIEOISOI-EOISOI-SOI-EOIEOI +1hSOI---
Sample time window Atezolizumab
[window]		[-24h, SOI]±5 min±10 min------[-24h, SOI]--[-24h, SOI]-[-24h, SOI]---[-24h, SOI]---
Laboratory AssessmentsT1
Disease AssessmentT1
IMP administration (IV infusion)T2
AtezolizumabT2X------------XX------------XXXXX
IsatuximabT2X--------------XX--------------XXX----------------XX----------------XX----------------XX----------------XXX------------XX------------XX
Pharmacokinetics14,22T2
Atezolizumab Sample IDT2S00-S01------S0016--S0016-S0016---S0016,23-SF00-
Isatuximab Sample ID22T2P0015--P0119P02P03P0417,20P0520P0619P0015,20-P0119P0015,20-P0015,20-P0119P02P0015,20---
Immunogenicity (ADA)14,18,22T2
Atezolizumab16T2AS00--------AS00--AS00-AS00---AS0023-ASF00-
Isatuximab20,22T2AP0015--------AP0015--AP0015-AP0015---AP0015--APF0021
Peripheral BloodT3
Immune genetic markersT3X
Tumor mutational profile (plasma cell free DNA)T3XXXX
Immunophenotyping25T3XXXX (odd cycles only)XX
Plasma or serum cytokines25T3XXXXX (odd cycles only)XX
Adaptive immunity26T3XX (only 1 on-treatment sample, see Study Reference Manual for details)X (only 1 on-treatment sample, see Study Reference Manual for details)X (only 1 on-treatment sample, see Study Reference Manual for details)
Plasma or serum Metabolites26T3XXXX (odd cycles only)X
Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM)T3
If feasible, biomarker analyses listed below for “Baseline or on treatment tumor biopsy core”27T3X
Baseline or on treatment tumor biopsy core in order of priority (Biopsy to be performed for HCC, SCCHN, and EOC if adequate archival tissue is not available)T3
Core 1T3
CD38 and PD-L1 expression, immune contexture (IHC analyses)28T3XX (if clinically feasible)
Core 2T3
CD38 and PD-L1 expression, immune contexture (IHC analyses)28T3XX (if clinically feasible)
Core 3T3
Transcriptomic analysis28T3XX (if clinically feasible)
▼ Matches across tables no matches to review
Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT03637764_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.
Refinements: a table or row that details a row of another table, without being the same activity. A cross-reference note can draft the entry once the table it means is picked; row-to-row entries are written by hand.
staterefining siderowactivitydraft
stated · ccorr-004 T2 act-003 Isatuximab refines T1 act-021 Isatuximab Administration xact-021 Table 2 gives the infusion timing for the administration row of Table 1; no source note. Kerstin Forsberg, 2026-10-03T08:53:15Z
stated · ccorr-005 T2 act-002 Atezolizumab refines T1 act-022 Atezolizumab Administration xact-022 Table 2 gives the infusion timing for the administration row of Table 1; no source note. Kerstin Forsberg, 2026-10-03T08:53:15Z
stated · ccorr-001 T2 act-004 Pharmacokinetics refines T1 act-025 PK xact-025 Table 1 note pr7 on this row: 'See Pharmacokinetics and immunogenicity Flow Chart'; Table 2 gives the per-sample timing. Kerstin Forsberg, 2026-10-03T08:53:15Z
stated · ccorr-002 T2 act-007 Immunogenicity (ADA) refines T1 act-026 ADA xact-026 Table 1 note pr7 on this row: 'See Pharmacokinetics and immunogenicity Flow Chart'; Table 2 gives the per-sample timing. Kerstin Forsberg, 2026-10-03T08:53:15Z
stated · ccorr-003 Table 3 (whole table) refines T1 act-027 Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw xact-027 Table 1 note pr8 on this row: 'See Biomarker Flow Chart'; Table 3 gives the collections by cycle. Kerstin Forsberg, 2026-10-03T08:53:15Z
source note 12 “See Pharmacokinetics and immunogenicity Flow Chart” points from T1 act-025 PK
T1 act-026 ADA
source note 13 “See Biomarker Flow Chart” points from T1 act-027 Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw
Draft — entries to append to consolidated/NCT03637764_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:32.083997+00:00
source_activity_count54
unified_activity_count54
compression_percent0
match_statsnew: 54
▼ Source Tables 3 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa SCHEDULE OF ACTIVITIES (SOA)
Main study schedule: screening, treatment cycles, end of treatment and post-treatment follow-up		 29 10 3
T2 subsidiary PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART
Per-sample PK and ADA timing (relative to start/end of infusion) for atezolizumab and isatuximab, with IMP infusion timing		 9 22 7
T3 subsidiary EXPLORATORY BIOMARKER FLOW CHART
Exploratory biomarker blood draws and tumor tissue/biopsy collection by cycle		 16 7 3
▼ Property Hierarchy Comparison 3 main timeline tables, 5 levels max

Compares main timeline tables only (main_soa, continuation, subsidiary). Track, domain, and reference tables excluded — different structure by design.

LevelT1T2T3Conclusion
L1
Study Phase
[epoch]
Top header band naming the study phases: Screening (up to 28 days before Day 1), Treatment Phase, End of Treatment (EOT), Post Treatment Follow-up Phase. Major study phases -> epoch. Label column is empty (the 'Evaluation' activity-column header spans all header rows), so the name is synthesised.
Study Phase
[epoch]
Study phase band: 'Treatment Phase' spans all cycle columns (2:21), 'Post-treatment' spans EOT and FUP (22:23). Major study phases -> epoch.
Study phase
[epoch]
Phase band: 'Screening' (4, cell merged down over the next header row), 'Treatment Phase' (5:8), 'Post-Treatment Phase' (9:10). Label columns hold the column captions 'Sample Collection' / 'Biomarker Analysis' (merged over all 3 header rows), so the name is synthesised. Major study phases -> epoch.
≈ Same type
L2
Cycle / Follow-up Period
[period]
Second header band sub-dividing the phases: Cycle 1, Cycle 2 and Beyond (treatment cycles of 21 days per footnote a), Safety follow-up Period, Survival follow-up; empty under Screening and EOT. Mixes treatment cycles with follow-up sub-periods, so classified as period (sub-phases) rather than cycle. Name synthesised (label column empty).
Cycle
[cycle]
Treatment cycles: Cycle 1 (2:10), Cycle 2 (11:13), Cycle 3 (14:15), Cycle 4 (16:19), Subsequent Cycles (20:21); EOT (22) and FUP (90±7 days) (23) are cells vertically merged across this row and the Day row, recorded on this row only. Repeating oncology cycles -> cycle.
Cycle / visit
[cycle]
Cycle 1, Cycle 2, Cycle 3, Cycle 5 and Beyond (no Cycle 4 column is printed), then EOT and Follow-up. Column 4 is covered by the vertically merged 'Screening' cell. Mostly treatment cycles -> cycle; EOT / Follow-up are visit-like values in the same row. Name synthesised (no row label).
≠ Differs
L3
Study Day / Visit Timing
[study_day]
Lowest header band giving the day of each column with its window: D-28 to D-15, D-14 to D-1, D1 (±1), D8 (± 1), D15 (±1), D1 (± 2), and relative follow-up days (30 (±7) days after last IMPs admin, At 60/At 90 (±7) days after last IMPs admin, Every 90 days (±7) after last safety follow-up). Protocol day values -> study_day. Name synthesised (label column empty).
Day within the Cycle
[study_day]
Day within the cycle: D1 (2:8), D15 (9:10) in Cycle 1; D1 for every later cycle. Columns 22-23 are covered by the vertically merged EOT / FUP cells from the Cycle row. Note the source prints the 72h and 168h (SOI of Day 8) columns under the Cycle 1 'D1' span. Day numbers -> study_day.
Day / timing
[study_day]
Day of cycle or relative timing: D-28 to D-1, D1 (-1 day)[a], D1, D1, D1, 30 (±7) days after last IMP admin, 60 (±7) days after last IMP admin. Predominantly study days -> study_day; the post-treatment values are offsets from last IMP. Name synthesised (no row label).
≈ Same type
L4—
Sample RNT (h) Ref: SOI Atezolizumab
[timepoint]
Atezolizumab relative nominal sampling times (SOI, EOI, EOI +30 min), referenced to atezolizumab start of infusion; '-' where no atezolizumab timepoint applies. Within-visit timing -> timepoint. Drug-specific: governs the atezolizumab PK/ADA rows. Parallel to row 6 (isatuximab scale); stacked levels 4 and 5 follow print order, not a parent-child relation.
—1/3 tables
L5—
Sample RNT (h) Ref: SOI Isatuximab
[timepoint]
Isatuximab relative nominal sampling times (SOI, EOI, EOI +4h, 72h, 168h (SOI of Day 8), EOI +1h), referenced to isatuximab start of infusion; '-' where no isatuximab timepoint applies. Within-visit timing -> timepoint. Drug-specific: governs the isatuximab PK/ADA rows. Parallel to row 4; this row carries the finest column split of the table.
—1/3 tables
Column Qualifiers
——
Sample time window Atezolizumab
[window]
Allowed sampling windows for the atezolizumab timepoints in row 4 ([-24h, SOI], ±5 min, ±10 min). Window qualifier of row 4; does not by itself distinguish columns -> level null.
—1/3 tables
▼ Unified Activities 54 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed consent/ Inclusion and exclusion criteria one table 1 T1
xact-002 Demography, Medical/Surgical and Disease History one table 1 T1
xact-003 Physical examination one table 1 T1
xact-004 Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM) one table 1 T1
xact-005 Vital Signs one table 1 T1
xact-006 Resting O2 saturation for SCCHN one table 1 T1
xact-007 12-Lead ECG one table 1 T1
xact-008 Laboratory Assessments one table 1 T1 section
xact-009 Pregnancy test (WOCBP only) Laboratory Assessments one table 1 T1
xact-010 Blood Chemistry Laboratory Assessments one table 1 T1
xact-011 Hematology Laboratory Assessments one table 1 T1
xact-012 Coagulation(GBM) Laboratory Assessments one table 1 T1
xact-013 Coagulation (for HCC, SCCHN, and EOC) Laboratory Assessments one table 1 T1
xact-014 Blood Typing Interference Test Laboratory Assessments one table 1 T1
xact-015 Serology HBV and HCV (for HCC only) Laboratory Assessments one table 1 T1
xact-016 Urinalysis (at baseline and if required) /urine dipstick Laboratory Assessments one table 1 T1
xact-017 Disease Assessment one table 1 T1 section
xact-018 CT/MRI (for HCC, SCCHN, and EOC) Disease Assessment one table 1 T1
xact-019 Brain MRI (for GBM only) Disease Assessment one table 1 T1
xact-020 AFP (for HCC) / CA125 (for EOC) Disease Assessment one table 1 T1
xact-021 Isatuximab Administration one table 1 T1
↳ refined by xact-032 Isatuximab T2 ccorr-004
xact-022 Atezolizumab Administration one table 1 T1
↳ refined by xact-031 Atezolizumab T2 ccorr-005
xact-023 AE/SAE Assessment one table 1 T1
xact-024 Prior/Concomitant Medication one table 1 T1
xact-025 PK one table 1 T1
↳ refined by xact-033 Pharmacokinetics T2 ccorr-001
xact-026 ADA one table 1 T1
↳ refined by xact-036 Immunogenicity (ADA) T2 ccorr-002
xact-027 Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw one table 1 T1
↳ refined by Table 3 (whole table) ccorr-003
xact-028 Subsequent Anticancer Therapy Status one table 1 T1
xact-029 Survival Status one table 1 T1
xact-030 IMP administration (IV infusion) one table 1 T2 section
xact-031 Atezolizumab
↳ refines xact-022 Atezolizumab Administration		 IMP administration (IV infusion) one table 1 T2
xact-032 Isatuximab
↳ refines xact-021 Isatuximab Administration		 IMP administration (IV infusion) one table 1 T2
xact-033 Pharmacokinetics
↳ refines xact-025 PK		 one table 1 T2 section
xact-034 Atezolizumab Sample ID Pharmacokinetics one table 1 T2
xact-035 Isatuximab Sample ID Pharmacokinetics one table 1 T2
xact-036 Immunogenicity (ADA)
↳ refines xact-026 ADA		 one table 1 T2 section
xact-037 Atezolizumab Immunogenicity (ADA) one table 1 T2
xact-038 Isatuximab Immunogenicity (ADA) one table 1 T2
xact-039 Peripheral Blood one table 1 T3 section
xact-040 Immune genetic markers Peripheral Blood one table 1 T3
xact-041 Tumor mutational profile (plasma cell free DNA) Peripheral Blood one table 1 T3
xact-042 Immunophenotyping Peripheral Blood one table 1 T3
xact-043 Plasma or serum cytokines Peripheral Blood one table 1 T3
xact-044 Adaptive immunity Peripheral Blood one table 1 T3
xact-045 Plasma or serum Metabolites Peripheral Blood one table 1 T3
xact-046 Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM) one table 1 T3 section
xact-047 If feasible, biomarker analyses listed below for “Baseline or on treatment tumor biopsy core” Archival Pre-Treatment Tumor Tissue Coll one table 1 T3
xact-048 Baseline or on treatment tumor biopsy core in order of priority (Biopsy to be performed for HCC, SCCHN, and EOC if adequate archival tissue is not available) one table 1 T3 section
xact-049 Core 1 Baseline or on treatment tumor biopsy co one table 1 T3
xact-050 CD38 and PD-L1 expression, immune contexture (IHC analyses) Core 1 one table 1 T3
xact-051 Core 2 Baseline or on treatment tumor biopsy co one table 1 T3
xact-052 CD38 and PD-L1 expression, immune contexture (IHC analyses) Core 2 one table 1 T3
xact-053 Core 3 Baseline or on treatment tumor biopsy co one table 1 T3
xact-054 Transcriptomic analysis Core 3 one table 1 T3
▼ Unified Annotations 28 annotations (0% dedup from 28)
Footnote (19)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 A cycle is 21 days D1 (±1) | D8 (± 1) | D15 (±1) | D1 (± 2)
xannot-002 2 T1:b 1 Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to first IMP administration. Pregnancy test (WOCBP only)
xannot-003 3 T1:c 1 evaluation not applicable for Cohort E Physical examination | Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM) | Vital Signs (+5) 16 cells
xannot-004 4 T1:n1 1 Informed Consent: Informed consent may be signed prior to D -28. Informed consent/ Inclusion and exclusion criteria
xannot-005 5 T1:n2 1 Section 10.3 Before each transfusion. Blood Typing Interference Test Section 10.3
xannot-015 15 T2:b 1 Isatuximab PK or ADA predose samples should be collected before isatuximab administration and at the same time as atezolizumab predose samples when applicable. Isatuximab Sample ID | Isatuximab 10 cells
xannot-016 16 T2:c 1 Atezolizumab sample collected strictly before the start of atezolizumab infusion (during treatment phase). Atezolizumab 4 cells
xannot-017 17 T2:d 1 P04 sample must be collected even if the participant withdraws the study without receiving the second administration of isatuximab. Isatuximab Sample ID 1 cells
xannot-018 18 T2:e 1 After start of study treatment, if 1 drug is prematurely discontinued, ADA samples for this drug will be collected and tested on Day 1 of the 2 next cycles. The ADA sample collection for other drug should be done as planned. Immunogenicity (ADA)
xannot-019 19 T2:f 1 Sample collected just before actual end of infusion of isatuximab. Isatuximab Sample ID 4 cells
xannot-020 20 T2:g 1 Isatuximab sample collected strictly before the start of isatuximab infusion (during treatment phase). Isatuximab 6 cells
xannot-021 21 T2:h 1 After FUP 90(±7) days after last isatuximab administration no further ADA will be sampled even if the status is positive or inconclusive. Isatuximab 1 cells
xannot-022 22 T2:i 1 Isatuximab PK and ADA samples to be collected each cycle until the last study treatment for PK and until FUP 90(±7) days after last IMP administration for ADA or at the cut-off date, whichever comes first. However, collection can be reduced or stopped earlier upon notification from the Sponsor based on the updated knowledge of isatuximab on PK/ADA. Pharmacokinetics | Isatuximab Sample ID | Immunogenicity (ADA) (+1)
xannot-023 23 T2:j 1 For subsequent cycles, atezolizumab PK and ADA samples (pre-dose) are to be collected at Cycle 8 Day 1 and Cycle 16 Day 1 only. Atezolizumab Sample ID | Atezolizumab 2 cells
xannot-024 24 T3:a 1 Biomarker blood draw may be performed within 1 working day prior to IMP administration. Cycle 1
xannot-025 25 T3:n1 1 Only for Phase 2 Stage 2 participants Immunophenotyping | Plasma or serum cytokines
xannot-026 26 T3:n2 1 Only Phase 2 Stage 2 participants, if sufficient clinical response is observable in Phase 1 and Phase 2 Stage 1 participants Adaptive immunity | Plasma or serum Metabolites
xannot-027 27 T3:n3 1 Mandatory for all GBM participants. For HCC, SCCHN, and EOC participants, provision of adequate archival tumor tissue is allowed to replace mandatory baseline biopsy If feasible, biomarker analyses listed below for “Baseline or on treatment tumor biopsy core”
xannot-028 28 T3:n4 1 Refer to I 02 for details. At least 1 tumor core is required, but 3 cores are optimal. Refer to Laboratory Manual for details. CD38 and PD-L1 expression, immune contexture (IHC analyses) | CD38 and PD-L1 expression, immune contexture (IHC analyses) | Transcriptomic analysis
Source Note (9)
xannot_idmarkers#textscopepoints to
xannot-006 6 T1:pr1 1 Section 8.2.1 Physical examination | Height (at baseline only) /Weight/ ECOG (HCC,SCCHN,EOC) or Karnofsky PS (GBM) Section 8.2.1
xannot-007 7 T1:pr2 1 See Section 8.2.2 Vital Signs | Resting O2 saturation for SCCHN Section 8.2.2
xannot-008 8 T1:pr3 1 See Section 8.2.3 12-Lead ECG Section 8.2.3
xannot-009 9 T1:pr4 1 See Section 10.3 Table 12 Blood Chemistry Section 10.3 · Table 12
xannot-010 10 T1:pr5 1 Section 10.3 Hematology | Coagulation(GBM) | Coagulation (for HCC, SCCHN, and EOC) (+2) Section 10.3
xannot-011 11 T1:pr6 1 Section 8.1 CT/MRI (for HCC, SCCHN, and EOC) | Brain MRI (for GBM only) | AFP (for HCC) / CA125 (for EOC) Section 8.1
xannot-012 12 T1:pr7 1 See Pharmacokinetics and immunogenicity Flow Chart PK | ADA
xannot-013 13 T1:pr8 1 See Biomarker Flow Chart Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw
xannot-014 14 T2:a 1 Refer to the laboratory manual for sample collection, processing and shipping. Pharmacokinetics | Immunogenicity (ADA)