A Phase II Clinical Trial of Pembrolizumab Efficacy and Safety in Advanced Renal Medullary Carcinoma
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. PD-L1, TIL Scoring, and Somatic Tumor Mutations
2.3. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Patient | Age at C1D1 | Gender | Race | Kidney Laterality | ECOG | Hemoglobin Electrophoresis Results | Stage at Initial Diagnosis of RMC | Metastatic Sites |
---|---|---|---|---|---|---|---|---|
1 | 24 | Male | Caucasian | right | 0 | Hb AS | Stage III (T3aN1M0) | 4 (3 lung nodules; T10 lesion) |
2 | 23 | Male | Black | Left | 1 | unavailable | Stage III (T3aNxMx) | Bilateral lung nodules |
3 | 47 | Female | Black | left | 1 | Unavailable | Stage IV (T1bNxM1) thoracic LN met | Local recurrence; Supraclavicular and RP LN |
4 | 23 | Male | Black | right | 1 | Hb AS | Stage IV (T1 N1 M1; left lung nodules) | Bilateral lung nodules; bilateral hilar LND; Left acetabular metastasis |
5 | 24 | Male | Black | Right | 1 | Hb AS | Stage IV (T1 N1 M1; 1.7 cm LLL nodule; bone and adenopathy at dx) | LLL nodule; bone metastasis (T2/T9) and RP adenopathy and hilar adenopathy |
Median Age (Range) | 24 (23–47) |
---|---|
Gender | |
Male (%) | 4 (80%) |
Female | 1 (20%) |
ECOG | |
0 (%) | 1 (20%) |
1 (%) | 4 (80% |
Prior line | |
0 | 1 (20%) |
1 | 2 (40%) |
2 | 2 (40%) |
Best response | |
Complete response | 0 |
Partial response | 0 |
Stable disease | 1 (20%) |
Progressive disease | 4 (80%) |
Duration from C1D1 to first PD | |
Range (weeks) | 0.7–12.7 |
Median (weeks) | 8.7 |
Mean (weeks) | 7.4 |
Adverse Effect | |
All grades | 1 (20%) |
Grade 1 or 2 | 1 (20%) |
Grade 3, 4 or 5 | 0 |
Immune related | 0 |
Status at time of trial end (9/30/20) | |
Alive | 1 (20%) |
Deceased | 4 (80%) |
PD-L1 H score * | |
range | 0–65 |
Median | 5 |
Mean | 18.5 |
Modified Proportion score ** | |
range | 0–65 |
Median | 5 |
Average | 13.4 |
Stromal interface | |
Yes | 2 (40%) |
No | (60%) |
3 |
Patient | Prior Cytoreductive Therapy | No. of Prior Systemic Therapy | No Platinum Base Therapy | Prior Systemic Therapy |
---|---|---|---|---|
1 | Yes | 1 | 0 | 1. Tazemetostat |
2 | Yes | 2 | 1 | 1. Tazemetostat 2. Carboplatin/Gemcitabine/Paclitaxel |
3 | Yes | 2 | 2 | 1. Carboplatin + Paclitaxel 2. Carboplatin + Paclitaxel + Avastin |
4 | Yes | 0 | 0 | No prior lines. |
5 | No | 1 | 0 | 1. Ixazomib + Adriamycin + gemcitabine |
Patient | Overall Response by irRECIST at Best Response (% Change from Baseline) | Duration from C1D1 to First PD/Last Response Assessment (Weeks) | PD-LI H-Score | MPS | TIL Infiltration (0–3) | NGS (Mutations Identified) |
---|---|---|---|---|---|---|
1 | 10% decrease + non-target PD | 8.9 | 5 | 5 | 3 | Yes (No actionable mutations) |
2 | 18% increase | 12.7 | 0 | 0 | 2 | Yes (BRAFV600E) |
3 | 61% increase | 8.7 | 65 | 45 | 3 | Yes (PTCH1 mutation) |
4 | 30% increase | 6.1 | 2 | 2 | 1 | No |
5 | Clinical progression | 0.7 | 20 | 15 | 3 | Yes (No identified mutations) |
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Nze, C.; Msaouel, P.; Derbala, M.H.; Stephen, B.; Abonofal, A.; Meric-Bernstam, F.; Tannir, N.M.; Naing, A. A Phase II Clinical Trial of Pembrolizumab Efficacy and Safety in Advanced Renal Medullary Carcinoma. Cancers 2023, 15, 3806. https://0-doi-org.brum.beds.ac.uk/10.3390/cancers15153806
Nze C, Msaouel P, Derbala MH, Stephen B, Abonofal A, Meric-Bernstam F, Tannir NM, Naing A. A Phase II Clinical Trial of Pembrolizumab Efficacy and Safety in Advanced Renal Medullary Carcinoma. Cancers. 2023; 15(15):3806. https://0-doi-org.brum.beds.ac.uk/10.3390/cancers15153806
Chicago/Turabian StyleNze, Chijioke, Pavlos Msaouel, Mohamed H. Derbala, Bettzy Stephen, Abdulrahman Abonofal, Funda Meric-Bernstam, Nizar M. Tannir, and Aung Naing. 2023. "A Phase II Clinical Trial of Pembrolizumab Efficacy and Safety in Advanced Renal Medullary Carcinoma" Cancers 15, no. 15: 3806. https://0-doi-org.brum.beds.ac.uk/10.3390/cancers15153806