Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus durvalumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
durvalumab plus tremelimumab vs. durvalumab alone | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE leading to treatment discontinuation (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus tremelimumab | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
durvalumab plus tremelimumab vs. tremelimumab | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE leading to treatment discontinuation (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4) | suggested 9.4-fold increase in DCR but the degree if certainty is unassessable | - |