1. Part 1 and Part 2, cohort 1 (expansion cohort - STS): Dose-limiting toxicity (DLT) (Time Frame - Day 1 to day 28): The primary endpoint is the frequency of DLTs which are relevant for the determination the tentative RP2D in Part 1 of the trial.
2. Part 2, Cohort 2 (phase IIa - melanoma): Disease control (DC) according to RECIST 1.1 (Time Frame - up to 12 weeks from treatment start): DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from start of treatment according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR, PR or SD (≥ 12 weeks) as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure.
Patients without any response assessment during trial treatment will be regarded as having a non-evaluable response (NE) and thus will be considered as failures for this endpoint.
Secondary outcome:
1. Objective response according to iRECIST (iOR) (Time Frame - up to 12 weeks from treatment start): iOR is defined as any complete response (CR/iCR) or partial response (PR/iPR) according to RECIST 1.1 or iRECIST criteria achieved during trial treatment until disease progression according to iRECIST, death or subsequent anticancer treatment, whichever occurs first. Any patient with CR/iCR or PR/iPR as best observed response during trial treatment until disease progression according to iRECIST, death or subsequent anticancer treatment (whichever occurs first) will be considered as a success; otherwise they will be considered as a failure.
Patients without any objective response assessment during trial treatment until disease progression according to iRECIST, death or subsequent anticancer treatment (whichever occurs first) will be regarded as having a NE and thus will be considered as failures for this endpoint.
2. Disease control according to iRECIST (iDC) (Time Frame - up to 12 weeks from treatment start): iDC is defined as any complete response (CR/iCR), partial response (PR/iPR) or stable disease (SD/iSD) for 12 weeks according to RECIST 1.1 or iRECIST criteria achieved during trial treatment until disease progression according to iRECIST, death or start of a subsequent anticancer treatment, whichever occurs first. Any patient with CR/iCR, PR/iPR or SD/iSD (≥12 weeks) as best observed response during trial treatment until disease progression according to iRECIST, death or start of a subsequent anticancer treatment (whichever occurs first) will be considered as a success; otherwise they will be considered as a failure.
Patients without any response assessment during trial treatment until disease progression according to iRECIST, death or start of a subsequent anticancer treatment (whichever occurs first) will be regarded as having a NE and thus will be considered as failures for this endpoint.
3. Duration of response according to iRECIST (iDoR) (Time Frame - from date of response until date of disease progression according to iRECIST or death due to disease progression, whichever occurs first, assessed up to 4 years): iDoR is defined as the time from the first documentation of iOR until disease progression according to iRECIST criteria (iPD) or death due to disease progression.
iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment showing no evidence of iPD before starting a subsequent anticancer treatment, if any.
4. Progression-free survival according to iRECIST (iPFS) (Time Frame - from treatment start until date of disease progression according to iRECIST or death due to any reason, whichever occurs first, assessed up to 4 years): iPFS is defined as the time from treatment start until disease progression according to iRECIST criteria (iPD) or death due to any reason, whichever occurs first.
iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment before starting a subsequent anticancer treatment, if any.
5. Objective response (OR) according to RECIST 1.1 (Time Frame - up to 24 weeks from treatment start): OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR or PR as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure.
Patients without any objective response assessment during trial treatment will be regarded as having a NE and thus will be considered as failures for this endpoint.
6. Disease control (DC) according to RECIST 1.1 (only for Part 2, Cohort 1) (Time Frame - up to 24 weeks from treatment start): DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from registration according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR, PR or SD (≥ 12 weeks) as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure.
Patients without any response assessment during trial treatment will be regarded as having a NE and thus will be considered as failures for this endpoint.
7. Duration of response (DoR) according to RECIST 1.1 (Time Frame - from date of response until date of disease progression according to RECIST 1.1 or death due to disease progression, whichever occurs first, assessed up to 4 years): DoR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1 criteria or death due to disease progression, whichever occurs first.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment before starting a subsequent anticancer treatment, if any.
8. Progression-free survival (PFS) according to RECIST 1.1 (Time Frame - from treatment start until date of disease progression according to RECIST 1.1 or death due to any reason, whichever occurs first, assessed up to 4 years): PFS is defined as the time from treatment start until disease progression according to RECIST 1.1 criteria or death due to any reason, whichever occurs first.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment before starting a subsequent anticancer treatment, if any.
IP-001: Dose and route: Immediately (within 15 - 30 min) after thermal ablation, IP-001 will be injected in and around the ablated lesion. The amount of IP-001 injected depends on the dose level.
Thermal Ablation (TRANBERG Thermal Therapy System® / Thermal Therapy System (Clinical Laserthermia Systems AB) / ): The medical device includes a laser unit. The system continuously measures the temperature of the tissue, guiding the user to perform precise and safe treatments.
Treatment time: 30 min
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors."
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