Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834973
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2021-03-29
Brief Title:
A Trial of Tigilanol Tiglate in Combination With Pembrolizumab in Stage IIIB to IV M1c-melanoma
Sponsor:
QBiotics Group Limited
Organization:
QBiotics Group Limited
Study Overview
Official Title:
A Phase IbIIa Dose-escalation Study to Evaluate the Safety Tolerability and Preliminary Effectiveness of Intratumoural Tigilanol Tiglate in Combination With Intravenous Pembrolizumab in Adults With Stage IIIb to IV M1c-melanoma
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Patient Recruitment Rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase IbIIa multicentre open label dose-escalation study to evaluate the safety tolerability and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients with unresectable Stage IIIB to IV M1c melanoma
Detailed Description:
Intratumoural treatment with tigilanol tiglate combined with systemic anti-programmed cell death receptor 1 PD 1 immunotherapy may enhance anti-tumour immune responses and improve outcomes for patients with melanoma
Primary Objectives
1 To determine the maximum tolerated dose MTD or maximum feasible dose MFD level of a single intratumoural treatment of tigilanol tiglate Tx1 administered in combination with pembrolizumab
2 To assess the safety and tolerability of i A single treatment Tx1 of intratumoural tigilanol tiglate at escalating dose levels dose-escalation administered in combination with intravenous IV pembrolizumab 200 mg and ii Repeat treatments of intratumoural tigilanol tiglate maximum of 3 treatments administered in combination with IV pembrolizumab 200 mg Q3W Repeat treatments of intratumoural tigilanol tiglate to be administered at the same dose level at Tx1 as follows
1 If the initially injected tumours are not fully ablated then intratumoural tigilanol tiglate Tx2 - Tx3 may be re-administered to the same tumours
2 If the initially injected tumours are fully ablated and additional pre-identified tumours can be treated then intratumoural tigilanol tiglate Tx2 - Tx3 may also be administered to those tumours
Note Tumours identified at Screening that are designated as not to be injected tumours ie non-injected tumours for observation cannot be treated at Tx1 Tx2 or Tx3
Secondary Objectives
1 To evaluate tumour response according to RECIST 11 criteria including loco-regional control of injected tumours and non-injected tumours and survival in patients treated in this study
2 To assess the safety and tolerability of ongoing treatment with pembrolizumab up to a total of 35 cycles Q3W including the combination with up to 3 treatments of intratumoural tigilanol tiglate Q3W
Exploratory Objectives
1 To evaluate the tumour response of tumours following treatment with intratumoural injection with tigilanol tiglate in combination with pembrolizumab
Primary Objectives
1 To determine the maximum tolerated dose MTD or maximum feasible dose MFD level of a single intratumoural treatment of tigilanol tiglate Tx1 administered in combination with pembrolizumab
2 To assess the safety and tolerability of i A single treatment Tx1 of intratumoural tigilanol tiglate at escalating dose levels dose-escalation administered in combination with intravenous IV pembrolizumab 200 mg and ii Repeat treatments of intratumoural tigilanol tiglate maximum of 3 treatments administered in combination with IV pembrolizumab 200 mg Q3W Repeat treatments of intratumoural tigilanol tiglate to be administered at the same dose level at Tx1 as follows
1 If the initially injected tumours are not fully ablated then intratumoural tigilanol tiglate Tx2 - Tx3 may be re-administered to the same tumours
2 If the initially injected tumours are fully ablated and additional pre-identified tumours can be treated then intratumoural tigilanol tiglate Tx2 - Tx3 may also be administered to those tumours
Note Tumours identified at Screening that are designated as not to be injected tumours ie non-injected tumours for observation cannot be treated at Tx1 Tx2 or Tx3
Secondary Objectives
1 To evaluate tumour response according to RECIST 11 criteria including loco-regional control of injected tumours and non-injected tumours and survival in patients treated in this study
2 To assess the safety and tolerability of ongoing treatment with pembrolizumab up to a total of 35 cycles Q3W including the combination with up to 3 treatments of intratumoural tigilanol tiglate Q3W
Exploratory Objectives
1 To evaluate the tumour response of tumours following treatment with intratumoural injection with tigilanol tiglate in combination with pembrolizumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KN-B16 | OTHER | None | None |
| U1111-1258-4085 | OTHER | WHO Universal Trial Number UTN | None |