Sample 78

NCT: NCT02570308 Model: local-qwen-0_5b RAG: no_rag
Deleted (in GT only) Added (in prediction only) Unchanged

Ground Truth

Inclusion Criteria:Male or female participants age ≥ 18 years of age at the time of informed consent.Ability to provide and understand written informed consent prior to any study procedures.Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma (mUM).Surgically sterile participants or participants of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug.Human leukocyte antigen (HLA)-A*0201 positive.ECOG Performance Status of 0 or 1 at Screening.Phase 2 will include participants with previously treated uveal melanoma in the metastatic setting.Exclusion Criteria:Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids.History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies.Participants with any out-of-range laboratory values.Clinically significant cardiac disease or impaired cardiac function.Active infection requiring systemic antibiotic therapy.Known history of HIV infection.Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol.Participants receiving systemic treatment with systemic steroid therapy or any other immunosuppressive medication at any dose level that would interfere with the action of the study drugs in the opinion of the investigator.Malignant disease, other than that being treated in this study.Any medical condition that would, in the investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.Pregnant, likely to become pregnant, or lactating women.

Prediction

Based on the revised eligibility criteria, here are the key modifications:
1.
**Study Duration**:
- From 20 to 40 patients in the RP2D-IE expansion cohort.
- From 20 to 40 patients in the Phase 2 dose expansion cohort.
2.
**Dose Level Adjustment**:
- From 20 mcg to 30 mcg in the RP2D-IE expansion cohort.
- From 20 mcg to 30 mcg in the Phase 2 dose expansion cohort.
3.
**Dose Limiting Toxicity Observation Period**:
- From 18 August 2015 to 18 August 2015.
- From 18 August 2015 to 18 August 2015.
4.
**Dose Escalation Rules**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
5.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
6.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
7.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
8.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
9.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
10.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
11.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
12.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
13.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
14.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
15.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
16.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
17.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
18.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
19.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
20.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
21.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
22.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
23.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
24.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
25.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
26.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
27.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
28.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
29.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
30.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
31.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
32.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
33.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
34.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
35.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
36.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
37.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
38.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
39.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
40.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation cohort.
- From 1 to 6 patients in the Phase 2 dose expansion cohort.
41.
**Dose Limiting Toxicity Observation Period**:
- From 1 to 6 patients in the Phase 1 dose escalation
← Sample 77 | Index | Sample 79 →