A Phase 2b Study of Immune Checkpoint Inhibition With or Without Dorgenmeltucel-L (HyperAcute Melanoma) Immunotherapy for Stage IV Melanoma Patients
Phase: PHASE2
Conditions: Stage IV Melanoma, Metastatic Melanoma
Sponsor: NewLink Genetics Corporation

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Pre-Clinical Experience of Dorgenmeltucel-L
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Clinical Experience of Dorgenmeltucel-L (HyperAcute Melanoma) 
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PreͲ
Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Mo Mo Mo Mo Mo Mo Mo Mo Mo Mo
Study
1
2
3
4
5
6
7
8
9
10
11
12
13
14
16
18
20
22
24
7
8
9
10
11
12
15
18
21
24
DAY
1
8
15
22
29
36
43
50
57
64
71
78
85
92 106 120 134 148 162
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
HAMInjections
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Ipilimumab
X
X
X
X
Informedconsent
X
Demographics
X
Medicalhistory
X
Concurrentmeds
X
Physicalexam
X
X
X
X
X
X
X
X
X
Vitalsigns
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Performancestatus
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CBCw/diff,plts
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serumchemistry
(withLDH)
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
bͲHCG
C
TSHandFreeT4
X
X
X
X
X
IgG,IgM,IgE
E
E
E
E
E
E
RCR
F
BloodforImmune
Assays(Tcells)
H
H
H
H
H
H
H
H
H
BloodforantiͲtumor
Ab
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
OptionalTumor
Biopsy
J
J
J
RadiologicTumor
(RECIST/iRRC)
evaluation
X
X
X
X
X
X
X
X
X
X
AE/SAEEvaluation
ͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲCompleteperSOCͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲ
ͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲEvaluatethroughoutStudyandFollowUpPerProtocolͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲ
EVALUATIONS
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PreͲ Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Mo Mo Mo Mo Mo Mo Mo Mo Mo Mo
Study
1
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4
5
6
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12
13
14
16
18
20
22
24
7
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DAY
1
8
15
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29
36
43
50
57
64
71
78
85
92 106 120 134 148 162
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
HAMInjections
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Nivolumab
X
X
X
X
X
X
X
X
X
X
X
Informedconsent
X
Demographics
X
Medicalhistory
X
Concurrentmeds
X
Physicalexam
X
X
X
X
X
X
X
X
Vitalsigns
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Performancestatus
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CBCw/diff,plts
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serumchemistry
(withLDH)
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
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bͲHCG
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X
X
X
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X
X
X
IgG,IgM,IgE
E
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RCR
F
BloodforImmune
Assays(Tcells)
H
H
H
H
H
H
H
H
H
BloodforantiͲtumor
Ab
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
OptionalTumor
Biopsy
J
J
J
RadiologicTumor
(RECIST/iRRC)
evaluation
X
X
X
X
X
X
X
X
X
X
AE/SAEEvaluation
EVALUATIONS
ͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲCompleteperSOCͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲ
ͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲEvaluatethroughoutStudyandFollowUpPerProtocolͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲ
ͲͲͲContinueevery2weekswithNivolumabͲͲͲ
ͲͲͲContinueevery2weekswithNivolumabͲͲͲ
ͲͲͲContinueevery2weekswithNivolumabͲͲͲ
ͲͲͲContinueevery2weekswithNivolumabͲͲͲ
ͲͲͲObtainatleastmonthlywithNivolumabͲͲͲ
XͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲX
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PreͲ
Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Wk Mo Mo Mo Mo Mo Mo Mo Mo Mo Mo
Study
1
2
3
4
5
6
7
8
9
10
11
12
13
14
16
18
20
22
24
7
8
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15
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24
DAY
1
8
15
22
29
36
43
50
57
64
71
78
85
92 106 120 134 148 162
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
Ͳ
HAMInjections
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Pembrolizamub
X
X
X
X
Informedconsent
X
Demographics
X
Medicalhistory
X
Concurrentmeds
X
Physicalexam
X
X
X
X
X
X
X
X
X
Vitalsigns
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Performancestatus
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CBCw/diff,plts
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serumchemistry
(withLDH)
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
bͲHCG
C
TSHandFreeT4
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X
X
X
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X
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E
E
E
E
RCR
F
BloodforImmune
Assays(Tcells)
H
H
H
H
H
H
H
H
H
BloodforantiͲtumor
Ab
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
OptionalTumor
Biopsy
J
J
J
RadiologicTumor
(RECIST/iRRC)
evaluation
X
X
X
X
X
X
X
X
X
X
AE/SAEEvaluation
EVALUATIONS
ͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲCompleteperSOCͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲͲ
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ͲͲͲͲͲͲͲͲͲͲContinuePembrolizamubevery3weeksͲͲͲͲͲͲͲͲͲͲͲ
ͲͲͲͲObtainatleastmonthlyduringPembrolizamub
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